Senior Quality Engineer - Design Controls RemediationBEPC Incorporated • Boston, Massachusetts, United States
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Senior Quality Engineer - Design Controls Remediation
BEPC Incorporated
- Boston, Massachusetts, United States
- Boston, Massachusetts, United States
Über
Determined based on experience (Paid weekly) Work Model: Onsite role Note
: This is a W2 only role — C2C, C2H will not be considered Summary of the position: BEPC is seeking a highly motivated Senior Quality Engineer – Design Controls Remediation (Medical Device / Cardiovascular) to join our client’s site in the Boston, Massachusetts area. This role will support critical remediation initiatives within a cardiovascular medical device environment focused on Design Controls remediation activities, including remediation of Design History Files (DHFs), assessment of design control documentation, and support of product development compliance activities throughout the design lifecycle. The ideal candidate will possess extensive experience with medical device Design Controls processes, DHF remediation, and regulatory compliance within Class II and/or Class III medical device environments. This individual will work cross-functionally with R&D, Quality, Regulatory Affairs, Manufacturing, and Program Management teams to ensure design documentation and processes meet FDA and ISO requirements. Summary of Duties and Responsibilities: Design Controls Remediation Lead and support remediation activities associated with Design History Files (DHFs) and Design Controls documentation. Review legacy DHF documentation to identify compliance gaps, missing deliverables, traceability deficiencies, and quality system risks. Remediate design documentation to ensure alignment with current regulatory requirements and internal procedures. Support remediation activities related to audit findings, FDA observations, CAPAs, and quality system improvement initiatives. Design Controls Lifecycle Support Provide quality engineering support across the entire Design Controls lifecycle, including: Design and Development Planning User Needs Design Inputs Design Outputs Design Verification Design Validation Design Reviews Risk Management Design Transfer Design Changes Design Traceability Ensure design activities are properly documented, reviewed, approved, and maintained within the DHF. DHF Component Remediation Remediate and/or develop key DHF deliverables and supporting documentation, including: Design and Development Plans Design Input Documents Design Output Specifications Design Verification (V&V) Protocols and Reports Design Validation Protocols and Reports Traceability Matrices Risk Management Files Hazard Analyses Design Review Documentation Requirements Traceability Design Transfer Documentation Engineering Change Documentation Ensure documentation is complete, technically accurate, and inspection-ready. Risk Management & Compliance Collaborate with cross-functional teams to ensure design risks are identified, evaluated, mitigated, and documented appropriately. Support integration of risk management activities into the design controls process in accordance with applicable standards. Ensure compliance with: FDA 21 CFR Part 820 ISO 13485 ISO 14971 Internal Quality Management System (QMS) procedures Cross-Functional Collaboration Partner with R&D, Systems Engineering, Manufacturing, Regulatory Affairs, and Program Management teams to support remediation timelines and deliverables. Participate in design reviews and provide quality and compliance guidance regarding design control expectations. Support change control and product lifecycle management activities related to design changes. Documentation & Audit Support Author, review, and approve design control documentation and remediation deliverables. Maintain accurate, organized, and audit-ready DHF documentation. Support internal audits, external audits, and FDA inspections related to Design Controls activities. Training & Mentorship Train and mentor personnel on Design Controls processes, DHF requirements, traceability expectations, and regulatory compliance best practices. Promote continuous improvement within product development and quality system processes.. Main Qualifications: Education: Bachelor’s degree in Engineering, Quality, Life Sciences, or related technical discipline. 8+ years of Quality Engineering or Design Quality experience in the medical device industry. Demonstrated experience remediating Design History Files (DHFs) and Design Controls documentation. Strong working knowledge of the complete medical device Design Controls lifecycle. Experience supporting Design Verification and Validation (V&V) activities and documentation. Working knowledge of: FDA 21 CFR Part 820 ISO 13485 ISO 14971 Design Controls and risk management processes Strong analytical, technical writing, and problem-solving skills. Excellent communication and cross-functional collaboration abilities. Preferred Qualifications: Experience in cardiovascular or Class II/Class III medical devices preferred. Previous remediation project experience supporting FDA commitments, Warning Letter responses, or audit remediation efforts. ASQ Certified Quality Engineer (CQE) or similar certification preferred. Experience with electronic document management systems (eDMS), PLM systems, and eQMS platforms. About BEPC BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth. Apply Now! Qualified candidates are encouraged to apply by submitting an up-to-date resume that highlights how your experience aligns with the role. Please include specific examples that demonstrate your qualifications. We look forward to connecting with you!
Sprachkenntnisse
- English
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