Quality Engineer # JN -072021-67235
Title : Quality Engineer
Location : Westford, MA
Duration : 06 months contract
- Serve as the QA representative on on-market development / change teams.
- Monitor design control related projects.
- Project planning issues
- Compliance Activities (DHF Audits, Traceability, etc.)
- Verification and Validation Status
- Participate in continuous improvement initiatives as appropriate for the design control system.
- Build and maintain successful cross functional relationships with internal departments such as R&D Engineering, Operations, Quality and Regulatory Affairs.
- Provide support, as needed, to Clinical Material Release, Quality Control, and Calibration programs.
- Assist in the development, approval, and change control of design history documentation (e.g. Design Inputs, Design Outputs, Trace Matrix, Design Verification/Validation, Change Impact Assessments, Quality Plans, Work Instructions, Protocols, Reports, FMEAs, etc.)
- Monitor and maintain DHF requirements in accordance with project timeline and design control requirements.
- Actively engage with Operations and Engineering to implement design control deliverables.
- Investigates/troubleshoots validation problems for product performance and /or equipment processes.
- Conducts statistical analysis of test data and process anomalies
- Writes, reviews approves and/or executes documentation for new and current verification & validation procedures and technical reports related to equipment, product and/or processes.
- Ensures company's adherence to the established Quality System and GMP/ISO standards, including management of new product Design History Files.
- Works with Engineering, Marketing, Manufacturing, Clinical and Regulatory to establish measurable, valid product requirements.
- Aides in definition / validation of test equipment, as required to accomplish quality responsibilities.
- Develops and documents test plans, procedures, protocols and reports.
- Executes and / or reviews tests according to various protocol requirements.
- Assists in completion of Risk Management (including cybersecurity) activities, including Risk Analysis, Use & Design FMEA, Plans and Reports.
- Works with R&D engineering to devise Design Verification and Validation plans for products based on performance specifications and risk analysis.
- Analyzes and communicates product test results / conformance to specifications and standards.
- Conducts technical and statistical investigations concerning optimization to specification and compliance to specification.
- Assists in definition and completion of in vitro testing including applicable animal studies.
- Assists in defining and measuring process capability, process controls, and process validation; assists in definition of Critical to Quality (CTQ) parameters.
- Aides in definition of supplier quality specifications, sampling plans, and vendor qualification.
- Assists in specifications and testing of sterilization methods.
EDUCATION AND EXPERIENCE
- Bachelors Degree in Mechanical/ Electrical Engineering, Engineering, Life Sciences, or Physical Sciences or related field.
- Minimum 2 years in Quality Assurance, Technical Quality, or equivalent; Knowledge in the areas of Design Controls, VV activities, manufacturing practices or processes, and statistical techniques.
- Working knowledge applicable regulations and standards such as FDA, QSR and ISO regulations.
- Demonstrated written, oral and interpersonal skills.
- Strong analytical skills, problem solving techniques and statistical application experience.
- Prior medical device experience
- Product software experience
- Device & Non-Device Software validation experience
- IEC6061, Capital equipment experience
- Risk Management process experience