Quality Systems Specialist Resume Sample
Noah Jacobson
1096 Leannon Plaza,
New York,
NY
+1 (555) 825 9916
Work Experience
Quality Systems Specialist
05/2017
-
PRESENT
Los Angeles, CA
- Under the direction of the Leader, Complaint Management Center, manages activities and procedures associated with complaints concerning BDDS products
- Accountable for setting own work direction and completing work tasks
- Supervise the processing of customer complaints including maintenance of complaint files, responses to customers and quality reports
- Responsible for a variety of mechanical and functional product evaluations related to the investigation of customer complaints. As well as supporting Market Segment Teams
- Responsible for processing of customer complaints specifically Medical Device Reports (MDR’s), including maintenance of complaint files, responses to customers and complaint reports
- Provide guidance and education regarding customer complaint processing, MDR’s, complaint report ability, and regulatory compliance
- Fills out decision trees when needed, after appropriate complaint investigation and files MedWatch reports after Leader reviews and approves
Senior Quality Systems Specialist
04/2011
-
04/2017
Dallas, TX
- Develops, administers and maintains the Quality System for conformance to Federal Regulations, International Standards and Corporate Policies/Procedures. Be familiar with products manufactured as well as the manufacturing process to assure compliance to Federal Regulations and International Standards as required
- Manages the plant’s corrective/preventive action system to assure consistency and accuracy of specifications and procedures necessary to manufacture products of the highest quality
- Actively participates in monthly Corrective Action Board/Continuous Improvement Committee (CAB/CIC) meetings and provide feedback as pertaining to Continuous Improvements
- Owns the plant internal audit program to ensure compliance to Federal Regulations and International Standards as required
- Plans and performs intensive audits of the plant systems and procedures. Coordinates plant audit teams to include training, scheduling, performing and reporting of audit
- Conducts supplier audits to ensure compliance with QSR/ISO as directed by material requirements and company guidelines
- Assists Quality Assurance personnel in addressing quality issues, as appropriate
- Conducts quality training as required to ensure compliance with Federal Regulations and International Standards where appropriate. Responsible for Quality Awareness and Good Manufacturing Practices training at all employee levels
Principal Quality Systems Specialist
07/2008
-
11/2010
Los Angeles, CA
- Works with other departments to maintain the highest quality standards
- Under the direction of the Leader, the Complaint Management Center, manages activities and procedures associated with complaints concerning BDDS products
- Able to manage the end to end process of customer complaints including review and maintenance of complaint files and responses sent to customer
- Utilization of database systems used to process complaints, create and measure Quality metrics and electronic MDR reports
- Responsible for reviewing customer complaints received for Medical Device Reports (MDR’s), FDA and ISO requirements
- Provide internal guidance and education regarding customer complaint processing, MDR’s, and regulatory compliance
- Files MedWatch reports after Leader reviews and approves
- Support Staff Specialists in the development, implementation and maintenance of Quality System processes required compliance to FDA 21 CFR 820, SOR/98-282, and ISO 13485
- Perform activity required to support /maintain controlled procedures and documents through the DMS System
Education
University of Wisconsin-Richland
2002 - 2007
Bachelor's Degree in Engineering
Professional Skills
- Two (2) years or more experience in the complaint handling, Medical Device industry, customer relations, complaint trending, MDR submissions, FDA regulations, GMP and where applicable clinical and other laboratory functions
- Strong analytical, deductive reasoning and listening skills, Strong Interpersonal skills
- Demonstrates organizational skills, integrity and strong time management
- Site audit prep activities. Proven skill mobilizing the site ensuring everyone and everything is ready for audit. Skilled at
- Robust trouble-shooting and problem solving ability and excellent communication and customer service skills
- Excellent written and oral communication skills (including technical writing)
- Strong problem solving, auditing and statistical skills
How to write Quality Systems Specialist Resume
Quality Systems Specialist role is responsible for organizational, computer, technical, interpersonal, analytical, basic, regulatory, microsoft, leadership, compliance.
To write great resume for quality systems specialist job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Quality Systems Specialist Resume
The section contact information is important in your quality systems specialist resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Quality Systems Specialist Resume
The section work experience is an essential part of your quality systems specialist resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous quality systems specialist responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular quality systems specialist position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Quality Systems Specialist resume experience can include:
- Strong Microsoft Office computer skills, and experience working with data analysis and problem solving tools
- Excellent verbal and written communication, problem solving, analytical skills required
- Excellent analytical skills. Able to use data to identify trends and understand problems
- + Strong problem-solving skills
- + Excellent oral and written communication skills
- Developed and utilised leadership skills in reaching individual objectives and team objectives
Education on a Quality Systems Specialist Resume
Make sure to make education a priority on your quality systems specialist resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your quality systems specialist experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Quality Systems Specialist Resume
When listing skills on your quality systems specialist resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical quality systems specialist skills:
- Excellent interpersonal communication, decision making, and leadership skills and ability to work effectively with both internal and external customers
- Communicate effectively at all levels, lead meetings and discussions and good written communication skills
- Demonstrated effective project management and technical writing skills
- Client-centric focus with good interpersonal skills and strong relationship-building knowledge
- Effectively manage multiple projects and priorities and is flexible with priorities and responsibilities
- Experience working effectively across geographies and working in a cross-functional team environment
List of Typical Experience For a Quality Systems Specialist Resume
1
Experience For Senior Quality Systems Specialist Resume
- Excellent oral and written communication skills. Ability to work and communicate effectively with all areas and levels of the organization
- Some experience of Quality Control experience and/or experience working with Contract Test Labs also desirable
- Effective communication skills, both oral and written is required
- Excellent computer skills – MS Office (Word, Excel, PPT, etc.)
- Troubleshooting skills/root cause investigation
- Exceptional written, verbal, and proofreading skills
2
Experience For Senior Quality Systems Specialist Computer Systems Resume
- Proficient computer skills using MS Office
- Effectively communicate both verbally and in writing to all levels within the organization and external to the organization
- + Consulting skills
- Strong experience with health authority inspections from major Health Authorities, e.g. USA, EMEA, Canada, Japan, Brazil etc
- + Communicates effectively with team, management, and other stakeholders to inform, exchange facts, ideas and perspective on issues
3
Experience For Principal Quality Systems Specialist Resume
- Be able to effectively work and collaborate with various functions, team members and levels within the organization
- Prioritize approval and release of Change Control documents based on business priorities
- Experience with API manufacturing, Aseptic/ Sterile Processing and Packaging and labelling
- Skilled at preparing metrics, project plans, and analyzing data to prepare detailed reports
- Site SME for Labeling Software – support trouble shooting issues and validation on upgrades
- Experience of managing engineering authorisations an advantage
- Experience creating agendas, writing minutes and follow up actions
4
Experience For IHS Quality Systems Specialist Resume
- Experience managing Quality Systems within medical device, pharmaceutical or manufacturing companies
- Experience writing and revising procedural documents
- Experience with problem solving/reasoning abilities
- Proven follow through on tasks – meeting deadlines
- Proven track record on working on own initiative
- Conduct Root Cause Investigations & Effectiveness Checks of Nonconforming Incidents
- Establish and maintain effective working relationships with external customers, peers, management and other cross-functional teams is required
- Assists with performing equipment validation reviews, data integrity as needed
5
Experience For Quality Systems Specialist, NCR & Capa Resume
- Experience using AMOS, Maintenix and/or Q-Pulse would be an advantage
- Experience with laboratory or manufacturing Quality Assurance
- Experience working cross-functionally across multiple sites and/or time zones
- Strong work ethic and ability to self-motivate while working independently
- Experience managing internal audit program
- Experience managing a corrective and preventive action program
- Experience in aseptic manufacturing
- + Computer literacy including strong knowledge of MS Word, Excel PowerPoint
- + Knowledge of Quality Management System principles, and 5+ years of experience working within a certified Quality System (ISO 13485 or similar)
6
Experience For Quality Systems Specialist Contract Position Until Dec Resume
- + An understanding of the codes under which Medtronic operate, for example
- Significant experience with learning management system functionality
- Experience leading global, cross functional projects
- Demonstrated Continuous Improvement mindset and capability
- Develop and implement effective Quality Management System measures e.g. Internal Audits, CAPA System
- Champion continuous QS improvement and effectiveness
- Experience in Quality Management area in automotive industry
- Evaluate/approve proposed changes, CAPA plans, and validation protocols/reports
- Support development of Annual Product Reviews for finished goods
7
Experience For Quality Systems Specialist Training & Technical Publications Focal Resume
- Coordinate validation system activities to ensure control of records, identify risks and establish compliance to company policies
- Experience with Non-Conformances or Corrective and Preventive Action’s is required
- Significant experience in the food or pharmacy Industry
- Experience in the food or pharmacy industry is preferable
- Develops and analyzes KPIs and metrics to evaluate overall program effectiveness
8
Experience For Quality Systems Specialist NDE Resume
- + Knowledge of or experience with working in a mature Quality Management System (preferably in ISO13485 or e.g. GMP or ISO9001)
- + Preferably experienced in conducting (supplier) audits
- + Preferably experienced in Lean Sigma or Improvement methodologies
- Develop effective and collaborative working relationships with other departments including Planning, Purchasing, Manufacturing, R&D and Operations
- + Experience with development of eLearning, SCORM training materials
9
Experience For Pr Quality Systems Specialist Resume
- Responsible for the archiving of Validation Protocols
- Quality systems experience, including ISO 9001:2015
- + Significant experience with learning management system functionality
- Experience handling multiple responsibilities with minimal direction
- Proven success in Operations Management roles (Manufacturing, Distribution, and Retail)
- Administrator for Sample Manager LIMS system with a strong understanding of Data Integrity requirements / compliance
- Strong MS Office with Word, Excel, and PowerPoint required
10
Experience For Configuration Assurance & Quality Systems Specialist Resume
- Multi-task and establish priorities is important
- Drive process integration, coordinate and prioritize changes and continuous improvement efforts. 20%
- + Previous experience in a regulated environment
- + MITG Quality System Experience
- Experience in FDA, GMP and ISO requirements
- Strong knowledge of systems and ISO requirements
List of Typical Skills For a Quality Systems Specialist Resume
1
Skills For Senior Quality Systems Specialist Resume
- Extremely strong communication, facilitation, planning, problem-solving, project management and organizational skills
- Excellent technical writing skills with ability to organize information in a sequence that makes sense to the reader is required
- Solid PC skills in MS Office and other reporting and productivity tools
- Effective organizational and planning skills; able to manage multiple documentation packages at the same time
- Strong Computer skills using MS OFFICE (Excel, Word, Power Point, Outlook etc.)
- Manufacturing and Production: A variety of skilled and unskilled labour and technical positions
- Adept and skilled at technical problem solving, having demonstrated and applied these learnings in a manufacturing environment
- Demonstrated experience in developing, implementing and maintaining Quality Management Systems, preferably in healthcare or laboratory environment
2
Skills For Senior Quality Systems Specialist Computer Systems Resume
- Related work experience or an equivalent combination of education and experience working in with programing and development
- Analytical, deductive reasoning and listening skills
- Experience training and/or implementing root cause analysis and effective investigation practices
- Effectively represent BD in customer facing role during audits
- A working knowledge of process improvement skills such as Lean Sigma
- Computer skills; working knowledge of Internet, MS Excel, Word, Outlook
- Strong experience in regulated environment (e.g. working with standards and regulations)
3
Skills For Principal Quality Systems Specialist Resume
- Knowledge of process improvement skills including six sigma, lean, knowledge-management, and process design
- Well defined problem solving and analytical skills
- Support the effectiveness of Quality System by working collaboratively with other stake holders to ensure effectiveness and compliant processes
- Intermediate computer skills required, including MS Windows, MS Word, MS Excel (use of pivot tables/charts and MS PowerPoint
- Verify that quality systems are effectively deployed
- Provide and implement recommendations to improve effectiveness of validation work
4
Skills For IHS Quality Systems Specialist Resume
- Works with US Sites validation teams to sustain validation activities
- Approving each training material prior to usage and control the set and recording of approved trainings
- Working Knowledge/Experience on the V22 tilt rotor platform
- Working with CAPA owners to plan and document investigations, action implementation and effectiveness verification on time and according to procedure
- Experience performing or supervising maintenance scheduling and documenting functions
5
Skills For Quality Systems Specialist, NCR & Capa Resume
- Experience providing guidance, coaching and/or training to other team members
- Experience in Tooling manufacturing and/or Tooling Quality Operations
- Manage multiple priorities including owning and balancing project management in conjunction with daily work
- + Experience of supplier quality management including supplier selection, supplier auditing, supplier monitoring and issue resolution
- Provides input to the Operating Unit team regarding overall OpU goals and priorities
- Experience interpreting contract requirements and developing Quality Plans
- Experience working with supplier management and providing flow downs to suppliers
- Relevant experience working in a medical device manufacturing environment
- Experience interfacing and presenting to senior and executive leadership
6
Skills For Quality Systems Specialist Contract Position Until Dec Resume
- Experience supporting internal quality audits and supporting Non-Conformance Investigations, CAPAs and Root Cause Investigations is required
- Proactive skill set to prevent data integration issues from occurring as well as action-oriented in bringing resolution to known data integration issues
- Experience in analyzing processes and identifying gaps
- Experience in facilitating diverse groups responsible for addressing quality issues
- Experience in decision-making, leadership, and team-building
- Experience leading or managing projects that involved cross-functional or cross-business unit teams
- Experience creating presentations using Microsoft PowerPoint
- Experience performing root cause corrective action / systematic problem solving
7
Skills For Quality Systems Specialist Training & Technical Publications Focal Resume
- Experience in interacting with health authorities including involvement with agency inspections
- Worked in fast pace manufacturing facility with shifting priorities
- Quality Engineering or Test Engineering experience
- Sound working knowledge of EH&S (Environmental Health & Safety) and experience in executing Risk Management activities
- Experience in training documentation in pharmaceutical GMP-regulated manufacturing industry
- + Sound working knowledge of EHS (Environmental Health Safety) and experience in executing Risk Management activities
- CAPA (Corrective / Preventive Action) Investigation experience, Internal Auditing, SOP / Technical writing
8
Skills For Quality Systems Specialist NDE Resume
- Applicants are encouraged to provide writing samples that demonstrate their capabilities in writing quality documentation and quality system procedures
- Applied experience in meeting and applying quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, etc.)
- Intermediate to advanced experience with charting and graphing tools
- Inspect hardware and initiate, review, and validate product non-conformances against engineering, manufacturing, and contract requirements
- Solid understanding of root cause analysis
- Provides input to the Quality Leadership team regarding Quality goals and priorities
- QMS auditor certification or previous auditing experience
9
Skills For Pr Quality Systems Specialist Resume
- Experience working with Electronic Document Management systems
- Experience guiding the successful completion of major programs in a project leadership role
- Experience working with non-conformances, corrective and preventive action reports
- Experience documenting corrective actions and non-conformances
- Two (2) years of quality experience in an IVD industry or in a cGMP, ISO regulated Medical Device manufacturing environment
- Experience and/or certification for internal auditing
10
Skills For Configuration Assurance & Quality Systems Specialist Resume
- Experience interfacing with senior and executive leadership
- Experience with and extensive knowledge of the COMNAVAIRFORINST 4790.2C document governing the Naval Aviation Maintenance Program
- Formal training with USMC Maintenance Controller MOS (or equivalent) or 10 years on the job experience in the Maintenance Controller function
- Experience with Technical Directives (TD) and Decision Knowledge Programming for Logistics Analysis and Technical Evaluation (DECKPLATE)
- Experience working with Interactive Electronic Technical Manual (IETM)
- Experience applying continuous improvement tools and techniques
- Quality Inspection experience, including FAI (First Article Inspection)
List of Typical Responsibilities For a Quality Systems Specialist Resume
1
Responsibilities For Senior Quality Systems Specialist Resume
- Knowledge of ISO-13485 and GMP; strong verbal, written, and analytical skills; detailed oriented with good organizational skills
- Communicate effectively at all levels. Ability to lead meetings and discussions.Good written communication skills
- Knowledge of LEAN Six Sigma principles and standard project management processes with ability to apply strong project management skills
- Excellent written and verbal communication skills. Able to adjust communication style to relate to all levels of the organization
- Strong knowledge / experience of cGxP, Computerised System Validation and Data Integrity required
- Detail oriented with excellent organizational and project management skills
- Excellent organizational, interpersonal, written and oral communication skills required
- Excellent interpersonal skills for dealing with changing and/or intangible situations and the ability to negotiate and influence those through the transitions
2
Responsibilities For Senior Quality Systems Specialist Computer Systems Resume
- Strong teaming, collaboration, negotiation and project/ time management skills
- Strong interpersonal skills and works well in team environment
- + Good communication/presentation skills
- + Versatile, methodic, multitask, strong organizational skills
- + Excellent communication skills, verbal and written in French and English
- Versatile, methodic, multitask, strong organizational skills
- Excellent communication skills, verbal and written in French and English
- Data analysis skills and experience is required
- Track record of excellent technical and communication skills, and the ability to work independently
3
Responsibilities For Principal Quality Systems Specialist Resume
- Proven ability and eagerness to learn new skill sets
- Demonstrates proficiency in Good Manufacturing Practices (GMPs)
- Prior experience in pharmaceutical industry essential
- Critical thinking skills, ability to multitask in a high-pace environment with fast deadlines, and ability to work well under pressure
- Experience in a regulated industry or equivalent combination of education and experience
- Solid experience within internal quality management and with proficiency as lead auditor for ISO 9001:2015
- Team player: ability to effectively communicate with cross-functional teams
4
Responsibilities For IHS Quality Systems Specialist Resume
- Teamwork and facilitation skills are required
- Skill at defining and prioritizing critical requirements
- Effectively project manage and/or participate in cross functional enterprise teams
- Superb ability to effectively communicate with staff members and business partners at all levels of the organization (both internal and external)
- Influence without authority and deal effectively with ambiguity
- + Qualified internal auditor is a strong asset, as well as supply management and/or risk management experience
5
Responsibilities For Quality Systems Specialist, NCR & Capa Resume
- Qualified internal auditor is a strong asset, as well as supply management and/or risk management experience
- Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint. SAP knowledge desired
- Effectively communicate (orally or via written communication) changes, updates, process
- Experience in Quality compliance or Quality Management Systems or 5+ years’ experience with MS
- Approachable with high level of emotional intelligence, awareness of political landscapes with the ability to negotiate effectively
6
Responsibilities For Quality Systems Specialist Contract Position Until Dec Resume
- Experience implementing and deploying new processes and systems
- Experience creating agendas, writing minutes and follow up actions.Quality Systems
- Provide information to maintain Validation Tracking Schedule (VTS)
- Ensure validation support structure and document handling systems are maintained
- Participate in Management Reviews and Executive Steering Committee meetings to report on Validation Status as assigned
- Extensive aviation engineering, quality and/or safety experience an advantage
7
Responsibilities For Quality Systems Specialist Training & Technical Publications Focal Resume
- Multi-tasking, organization and prioritization of assignments
- Experience working in a regulated environment under 21CFR Part 820 and ISO13485
- Adapt to rapidly changing priorities, handle multiple tasks and meet deadlines
- Experience working in a Quality Systems role in the pharmaceutical industry
- + Min. 5 years of relevant quality working experience in medical technology, logistical and operational environment or healthcare service environment
- + Experience in project management, working on complex problems where analysis of situation or data requires an in-depth evaluation of various factors
- + Demonstrate commitment to excellence by delivering measurable results that equal or exceed stretch targets
- Experience working with FDA Quality Systems Requirements
8
Responsibilities For Quality Systems Specialist NDE Resume
- + 5+ years of experience working within a certified Quality System
- Experience in the medical device industry including knowledge of FDA and ISO and other related industry regulations required
- Computer literacy including strong knowledge of MS Word, Excel & PowerPoint
- Knowledge of Quality Management System principles, and 5+ years of experience working within a certified Quality System (ISO 13485 or similar)
- An understanding of the codes under which Medtronic operate, for example
- Experience working within a certified Quality System
- Experience in project management, working on complex problems where analysis of situation or data requires an in-depth evaluation of various factors
9
Responsibilities For Pr Quality Systems Specialist Resume
- Demonstrate commitment to excellence by delivering measurable results that equal or exceed stretch targets
- Experience working with a cross-functional team and collaboration with a Quality organization
- Experience with Contract Manufacturing Operations (CMO)
- Thorough understanding and experience with quality systems, cGMPs, GDPs
- Review all customer complaints, investigations and communications for validity and assures compliance with policies and procedures
- Develop, implement and execute initiatives to improve the user experience with and compliance of the Quality System
10
Responsibilities For Configuration Assurance & Quality Systems Specialist Resume
- Develop, implement and report on measures of quality system effectiveness
- Support the CAPA system and ensure timely closure and effectiveness of investigations and corrective and preventive actions
- Conduct customer/ regulatory audits; determine and implement effective corrective actions
- QA or QC experience
- Experience with database development and system integration
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