Quality Assurance Specialist
Sorry, this particular job is closed. But feel free to fill out a General ApplicationSearch Jobs
Quality Assurance Specialist
Title:Quality Assurance Specialist
Our client in Marlborough, MA is looking for a Quality Assurance Specialist, on a direct hire basis. This is a great opportunity for someone looking for growth and development.
- Knowledge of FDA Quality System Regulation, cGMP and ISO 13485: 2016, as they pertain to the medical device industry.
- Performs product release activities including review of DHRs, sterilization records and post-production release documents.
- Coordinates and conducts technical investigation and documentation of non-conforming events and corrective/preventative action.
- Review Quality and Operations key performance indicators and support the compliance effort of the Quality team.
- Creates, controls and maintains training documents and document files.
- Support and conduct New Employee training and provides training support, as applicable.
- Collect training records, checks for accuracy, completeness, and obtains corrections when necessary.
- Reviewing all types of documentation for completeness and accuracy. This includes manufacturing assembly, data calculation and log entries, supplier documents and test documents.
- Develop and implement quality data reporting and analysis function to support the overall Quality Management System.
- Provides critical information for audits and reviews/analyzes data and documentation.
- Identify and address any potential quality impact.
Education & Experience Requirements:
- Bachelor’s degree (B.S.) or equivalent in related field.
- 2-3 years related experience in an FDA QSR, cGMP, ISO 13485 compliant environment.
- Strong knowledge of FDA Quality System Regulation (QSR) with an emphasis on Production Controls.
- Prior medical device experience, highly desirable.
- Experience in a manufacturing facility preferred.
- Detail-oriented, possess excellent verbal and written communication skills, good interpersonal and organizational skills and be a team player.
- Proven problem-solving skills.
- Must be able to interpret variety of technical instructions.
- Advanced skills in Word, Excel and other MS Office applications.
- Ability to partner effectively throughout the organization to maintain compliance and foster a quality mindset.
- Material Handler (Production) in Westborough MA
- Maintenance Mechanic - 3rd shift in Lincoln RI
- Electrical Technician in Audubon PA
- Distribution Associate I in Memphis TN
- Quality Technician in Memphis TN
- Electrical Engineering Technician in Milford MA
- Stockroom Clerk in Gainesville GA
- Entry Level Mechanical Design Engineer in Bedford NH
- Test Technician in Acton MA
- Contract Technical Writer in Milford MA
- Software & Automation Engineer in Bedford MA
- Financial Analyst II in Milford MA
- Temp Cycle Count Associate in Holliston MA
- 2nd Shift Fulfillment Supervisor in Plymouth MA
- Maintenance Mechanic in Plymouth MA
- Test Engineer in Manchester NH
- Customer Operations Support Associate in Lowell MA
- Tack Welder in Duluth GA
- Shipping and Receiving Clerk in Santa Ana CA
- Synthesis Operator, 2nd shift in Taunton MA
- Maintenance Technician in Lawrenceville GA
- Senior Manufacturing Engineer in Winston-Salem NC
- Receptionist-Support specialist in Memphis TN
- Inside Sales Rep in Golden CO
- Senior Packaging Compliance Engineer in Woburn MA
- Lead Maintenance Mechanic in Memphis TN
- Temp Help in Duluth GA
- Software Quality Assurance Engineer in Merrimack NH
- Senior Operations Quality Engineer in Milford MA
- Manufacturing Technician in Wilmington MA
- Director of Program Management in Providence RI
- Senior Mechanical Engineer in Woburn MA
- Principal Electrical Engineer - FPGA in Merrimack NH
- Sr Engineering Technician in Merrimack NH
- Maintenance Mechanic in Minneapolis MN
- Kitting-Assembler in Holliston MA
- Shipper-Receiver in Taunton MA
- Electronics Assemblers, Technicians & Solderers in Burnsville MN
- RMA Technician in Lawrenceville GA
- Enclosure Assembler in Roswell GA
- Assembly Technician in Alpharetta GA
- Solderer Technician 1st shift in Alpharetta GA
- Client Services Representative in Lenexa KS
- Compressor Operation – Material Handler in Flowery Branch GA
- Mechanical Engineer in Merrimack NH
- Shipper- Warehouse Associate in Ashland MA
- Design Engineer in Spartanburg SC
- Run Test Supervisor in Selma TX
- Debug Technician in Westford MA
- Mechanical Assembler in Westford MA
- Contracts Administrator in Lowell MA
- Shipping Associate in Suwanee GA
- Executive Admin Assistant in Milford MA
- Pricing Data Analyst in Milford MA
- Manufacturing Supervisor in Danvers MA
- Jr Production Planner-Scheduler in Dartmouth MA
- Maintenance Mechanic in St Paul MN
- Production Tech in Golden CO
- Maintenance Technician in Suwanee GA
- Shipping and Receiving Clerk in Buford GA
- Pillar House Selective Soldering Machine Operator in Manchester NH
- Equipment Operator 1st Shift in Jefferson GA
- First shift Machine Operator in Plymouth MA
- Facilities Mechanic in Plymouth MA
- Electrical Designer in Alpharetta GA
- Calibration Techs in Portsmouth NH
- Controls Engineer in Portsmouth NH
- Pulse Arc MIG Welder in Flowery Branch GA
- CNC Programmer in Olive Branch MS
- Senior Machinist in Olive Branch MS
- Machinist in Olive Branch MS
- Design Assurance Engineer in San Antonio TX
- Senior Electrical Engineer in Framingham MA
- CNC Machinist in Plymouth MA
- Mechanical Inspector in Plymouth MA
- Technical Recruiter - MA in Marlborough MA
- Supply Replenisher in Long Branch NJ
- Senior Accountant in New Castle DE
- Cable Cutting - Assembly in Alpharetta GA
- Software Engineer in Providence RI
- Quality-Weld Inspector in Doraville GA
- Welder 2nd Shift in Duluth GA
- Technical Support Representative in Marlborough MA
- Shipping Clerk - Methuen in Methuen MA
- Manufacturing Tech in Eden Prairie MN
- Digital Content Writer in Milford MA
- Electrical Engineer in Wilmington MA
- Material Handler (Production) 9-18-19 in Westborough MA
- Quality Inspector- 2nd shift in Bloomfield CT
- Test Tech- 2nd shift in Manchester NH
- Catheter Assembler in Marlborough MA
- Engineering Manager in Memphis TN
- Executive Assistant in Memphis TN
- Sr Process Development Engineer in Sunrise FL
- Molding Process Engineer in Upland CA
- Manufacturing Engineer II in Memphis TN
- Quality Control Inspector in Methuen MA
- Manufacturing Engineer in Memphis TN
- Buyer Coordinator in Minneapolis MN
- Quality Inspector II - RII in Westborough MA