QA Engineer RainDance Technologies
Location: Billerica, MA
Department: Quality Assurance
Category: Operations, Manufacturing
Salary: Commensurate With Experience
Benefits: Full Benefits
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The ideal candidate is a technically-proficient self-starter who jumps in and solves challenging problems while relishing a fast-paced environment. The Quality Engineer supports new product development and product maintenance through the application of Quality Engineering Body of Knowledge. This position requires ongoing interface with Program Manager, Engineering, Manufacturing, Purchasing, R&D, and Suppliers. Additionally, this individual will play an active role in the processes to ensure products meet quality standards while meeting all design control and other regulatory requirements. This person will handle multiple projects and tasks, from product inception through product launch and maintenance.
Provide direct support and in some instance lead effort to establish an ISO 13485 and QSR compliant Quality Management System.
Support of various quality systems including but not exclusive to: Management controls, Corrective and Preventive Actions (CAPA), Training, Batch Record Review, Calibration, Complaint Investigation (customer feedback), Deviations, Rework, Inspections, Non-conforming Material Reporting and MRB.
Perform and compose detailed reports on internal audits
Promote Good Laboratory Practices and comply with site safety and health hazard requirements when working in the lab and when working with lab personnel.
Reviews/approves change control documents including design drawings for tolerances, inspect-ability and quality of design issues.
Develops procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
Review Non-Conforming Material (NCMR) as a representative of Quality Assurance on the Material Review Board (MRB).
Provide assistance and support to all functional management (stakeholder) in helping them determine their FDA/ISO compliance needs and to assigned projects such as Quality System Deployment, Product Development, Training, Auditing, and Supply Management.
Support the implementation practices/procedures for selection of suppliers into the Approved Supplier List (ASL)
Develops process improvement plans using a variety of Quality tools (e.g. Six Sigma, Lean Manufacturing, 5S, SPC, engineering studies, DOE, Gauge R&R, etc.)
Develop Quality metrics and reports: Supplier performance, customer complaints, CAPAs, nonconforming material, Training, Rework, Deviations, and other quality costs.
Interface with intra and inter site personnel to facilitate timely analysis of customer return product classified as a complaint.
Develop protocols/plans/procedures/requirements for testing of returned customer complaint units in support of company?s quality program
Manage failure investigations including root cause determinations and documentation of findings
BS Engineering and/or Science Related discipline
Minimum 3 years of Quality Engineering experience in Medical Device/IVD or Life Sciences industry OR solid background in QSR and MDD/IVDD Quality System requirements
Working knowledge of ISO 9001, 13485, and QSR?s.
Experience driving resolution and documentation of Non-Conforming Material per MRB processes.
Experience investigating and closing out Corrective / Preventive Actions.
Working knowledge of electro mechanical assembly
Experience with Source Inspection and Supplier Audits.
Excellent computer systems and MS Office skills.
Detail-oriented team player, strong interpersonal, written and communication skills.
This position is in an office environment, with interaction with laboratories, assembly manufacturing and external suppliers.
Able to communicate at all organizational levels and with outside companies. Able to work well in a team environment with peer group.
Minimum of a Bachelor's Degree in Engineering or related discipline is required
5-7 years experience in Quality Engineering
3-5 years engineering experience in the medical device
Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) and/or Regulatory Assurance Certification (RAC) desirable.
Working knowledge of Geometric Dimensioning and dimensional inspection.
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