Senior Design Quality Engineer Medical Device W2 preffered

Role name: Senior Design Quality Engineer
Work Location: Andover MA
Start date: Immediate availability
Job Type: Contract (C2C/W2)
Interview: Phone/Video

Role and responsibilities:
Grade: C2> 10-12 years
Location: Andover MA/Remote
Working from client office: Yes (Hybrid 3 days per week).

Qualifications:
o Bachelors degree in Engineering (Biomedical Software Systems) or a related technical discipline
o Advanced degree (Masters) in Engineering Quality or Regulatory Affairs preferred
o Relevant certifications (e.g. ASQ CQE CSQE Six Sigma Green/Black Belt) are a plus

Job Description
As a Senior Design Quality Engineer (DQE) for our medical device manufacturer client in the Greater Boston region you will be responsible for ensuring endtoend design quality and compliance across the product development lifecycle for Class II/III medical devices including software-driven and active implantable products. Working directly with cross-functional teams you will drive adherence to design controls risk management and SDLC best practices from concept through commercialization and postmarket activities.

Key Responsibilities
In this role you will play a key role in:
Serving as the quality lead on product development teams ensuring compliance with design controls across all lifecycle phases (planning inputs/outputs verification validation transfer and change management)
Establishing and maintaining DHF DMR and DHR ensuring complete traceability from user needs through verification and validation evidence
Leading and maintaining risk management activities (hazard analysis FMEA risk files) and ensuring integration of risk controls into design and validation activities
Providing quality oversight of software SDLC activities ensuring compliance with applicable standards (e.g. IEC 62304) and integration with system-level risk management
Reviewing and approving design software and validation deliverables to ensure completeness consistency and audit readiness
Supporting verification validation and design transfer activities ensuring alignment between design outputs and production processes
Leading or supporting CAPA nonconformance investigations and root cause analysis to drive continuous improvement
Supporting internal and external audits (FDA Notified Body ISO) and contributing to regulatory submissions (e.g. IDE PMA EU MDR)

Required Skills
10 years of experience in Quality Engineering supporting regulated medical device development (Class II/III preferred)
Strong hands-on experience with design controls DHF management and traceability in regulated environments
Working knowledge of applicable standards and regulations (e.g. 21 CFR 820 ISO 13485 ISO 14971 IEC 62304)
Experience supporting software quality within the SDLC and understanding of software risk management principles
Proven experience with risk management tools (e.g. FMEA hazard analysis) and integration into product development
Experience supporting audits and regulatory submissions with the ability to defend design and quality documentation
Strong analytical documentation and communication skills with ability to work effectively across cross-functional teams
Experience with quality systems eQMS/PLM tools and defect/CAPA management processes

Additional Information :

All your information will be kept confidential according to EEO guidelines.

Remote Work :

No

Employment Type :

Contract