Quality Engineer; Medical Device-(USC​/GC

Job Title:

Quality Engineer (Medical Device)-(USC/GC Only)

Pay Rate: $65 to $70/hr

Duration:
12 months

Location:

Newton, MA

We are looking for a Quality Engineer (Medical Devices).

• Serve as the Quality representative and Design Controls lead on cross-functional teams developing complex electromechanical and robotic medical systems.
• Own and support Design Control activities across the product lifecycle in accordance with FDA QSR (
  21 CFR 820.30),
  ISO 13485
  , and applicable regulations.
• Support definition and approval of system- and subsystem-level design inputs that are clear, testable, and aligned to intended use and risk.
• Maintain end-to-end traceability between design inputs, outputs,
  risk controls,
  verification
  , and validation
  .
• Support design reviews, phase gate readiness, and Design History File (
  DHF
  ) completeness.
• Lead and support risk management activities per ISO 14971 using a system-level, top-down, and bottom-up approach.
• Ensure risk controls are implemented and verified, and residual risk is supported by objective evidence.
• Support tolerance, worst-case, and margin analyses as inputs to risk assessment and verification planning.
• Provide Quality oversight of design verification and validation (V&V) planning, execution, and reporting.
• Review and approve V&V protocols and reports to ensure adequate coverage of requirements, risks, and regulatory expectations.
• Support electrical safety and EMC compliance testing, including IEC 60601-1, IEC 60601-1-2, and IEC 80601-2-77, as applicable.
• Collaborate with Software Quality and Systems Engineering to ensure HW/SW integration risks are addressed.
• Support supplier qualification and design transfer for design-critical components and interfaces.
• Support preparation and review of Design Control
  , risk
  , and V&V documentation for IDE, De Novo, and/or PMA submissions.

• Supporting the collection and analysis of performance metrics.
• Proposing and leading Corrective and Preventive Actions (
  CAPAs
  ).
• Leading and/or participating in product complaint investigations leading to root cause.
• Assisting in the disposition of non-conforming material.
• Supporting other duties as assigned by the manager.

• Minimum 4-year degree in Engineering, Biomedical Engineering, or Life Sciences.
• 7 to 10 years of experience as a Quality or Design Quality Engineer in the medical device industry supporting the development of complex electro-mechanical Class III devices is required.
• Working knowledge of QSR, MDD/MDR
  , ISO
  -13485, and ISO-14971 is required.
• Experience supporting the development of compliant medical device software or SaMD (i.e,
  IEC 62304/82304
  ) and SWFMEA development is required.
• Experience in applied statistics, including the use of Minitab or other statistical analysis software, is required.
• Experience in CAPA, NCMR
  , and complaint investigations is required.
• Familiarity with electrical component handling and ESD controls is required.

Experience with supporting De Novo/PMA submissions is preferred.

• Effective and professional communication skills with both internal and external stakeholders.
• Effective written communication skills, with the ability to author clear, concise, and accurate procedures, analyses, protocols, and reports.
• Effective time/task management skills; excel in working in a fast-paced environment.