Quality Engineer # JN -072021-67235

Title                           : Quality Engineer

Location                    : Westford, MA

Duration                   : 06 months contract

RESPONSIBILITIES:

• 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

Required

• 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.

Preferred

• Prior medical device experience
• Product software experience
• Device & Non-Device Software validation experience
• IEC6061, Capital equipment experience
• Risk Management process experience