Senior Quality Engineer - Nonconformance (NC) Remediation

BEPC is actively looking for Senior Quality Engineer – Nonconformance (NC) Remediation (Medical Device / Cardiovascular), in Boston, MA area!

W2 Contract – 18 to 24 months with possible extensions!

Benefits include medical, dental, vision, and life insurance

Pay Rate: $59.00 - $69.00 /hour - 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 – Nonconformance (NC) Remediation to join our client’s site in the Boston, Massachusetts area. This role will support a critical remediation initiative focused on the remediation, investigation, and resolution of Nonconformances (NCs) while strengthening quality system compliance and manufacturing process controls.

The ideal candidate will possess strong experience in medical device manufacturing, nonconformance management, risk assessment, and quality systems compliance. This individual will work cross-functionally with Manufacturing, Engineering, Quality, and Operations teams to investigate issues, implement corrective actions, and support sustainable process improvements in accordance with FDA and ISO requirements.

Summary of Duties and Responsibilities:

Nonconformance (NC) Remediation & Management

• Lead and support remediation activities associated with legacy and ongoing Nonconformances (NCs) within a regulated medical device manufacturing environment.
• Review and assess existing NC records to identify compliance gaps, documentation deficiencies, and systemic quality issues.
• Drive NC investigations through initiation, evaluation, disposition, and closure while ensuring compliance with internal procedures and regulatory expectations.
• Support remediation activities related to audit findings, FDA observations, quality events, and manufacturing deviations.

Investigation & Root Cause Analysis

• Conduct thorough investigations into product and process nonconformances using structured problem-solving methodologies.
• Partner with Manufacturing, Engineering, and Quality teams to determine root causes and identify appropriate corrective actions.
• Analyze trends in NC data to identify recurring issues and opportunities for continuous improvement.

Risk Assessment & PFMEA Support

• Utilize Process Failure Modes and Effects Analysis (PFMEA) methodologies to assess manufacturing risks associated with nonconformances.
• Support risk evaluations and determine the potential impact of NCs on product quality, patient safety, and regulatory compliance.
• Collaborate with cross-functional teams to update PFMEAs and related risk management documentation as needed.

Manufacturing Process Support

• Provide quality engineering support for medical device manufacturing processes, including:
• Process controls
• Production quality issues
• Material review activities
• Product disposition decisions
• Work closely with manufacturing teams to improve process capability, reduce defects, and strengthen quality controls.
• Ensure remediation activities align with Good Manufacturing Practices (GMP) and applicable quality system requirements.

Training & Mentorship

• Train and mentor personnel on Nonconformance processes, investigation techniques, documentation requirements, and quality system expectations.
• Support continuous improvement initiatives by promoting best practices in NC management and quality compliance.

Documentation & Compliance

• Author, review, and maintain NC documentation to ensure records are accurate, complete, and audit-ready.
• Support compliance with:
• FDA 21 CFR Part 820
• ISO 13485
• Internal Quality Management System (QMS) procedures
• Assist during internal audits, external audits, and regulatory inspections as needed.

Main Qualifications:

• Education: Bachelor’s degree in Engineering, Quality, Life Sciences, or related technical discipline.
• 8+ years of Quality Engineering experience in the medical device industry.
• Demonstrated experience leading and remediating Nonconformances (NCs) in regulated manufacturing environments.
• Strong understanding of medical device manufacturing processes and Quality Management Systems.
• Experience utilizing risk management tools such as PFMEA.
• Working knowledge of:
• FDA 21 CFR Part 820
• ISO 13485
• Nonconformance and quality event 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, audit findings, or Warning Letter activities.
• ASQ Certified Quality Engineer (CQE) or similar certification preferred.
• Experience with electronic Quality Management Systems (eQMS).

Key Competencies:

• Nonconformance Management
• Root Cause Investigation
• PFMEA & Risk Assessment
• Medical Device Manufacturing Support
• Regulatory Compliance
• Quality Systems Expertise
• Cross-Functional Collaboration
• Technical Documentation
• Training & Mentorship
• Continuous Improvement.

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!