Senior Quality Engineer – Complaint Handling Remediation (Boston)

BEPC is actively looking for Senior Quality Engineer – Complaint Handling Remediation (Medical Device / Cardiovascular), in Boston, MA area!W2 Contract – 18 to 24 months with possible extensions!Benefits include medical, dental, vision, and life insurancePay Rate: $59.00 - $69.00 /hour - Determined based on experience (Paid weekly)Work Model: Onsite roleNote: This is a W2 only role — C2C, C2H will not be consideredSummary of the position:BEPC is seeking a highly motivated Senior Quality Engineer – Complaint Handling Remediation to join our client's site in the Boston, Massachusetts area. This role will support a high-visibility remediation project within a cardiovascular medical device manufacturing environment.This role will focus on the remediation, investigation, and resolution of product complaints while ensuring compliance with applicable regulatory and quality system requirements.The ideal candidate will possess strong experience in medical device complaint handling, root cause investigations, risk analysis, and manufacturing quality systems. This individual will work cross-functionally with Quality, Manufacturing, Engineering, Regulatory Affairs, and Post-Market Surveillance teams to strengthen complaint processes, improve compliance, and support remediation objectives.Summary of Duties and Responsibilities:Complaint Handling & RemediationLead and support remediation activities associated with legacy and ongoing product complaints within a regulated medical device environment.Review and assess complaint records to identify documentation gaps, compliance deficiencies, and systemic quality issues.Drive complaint investigations from initiation through closure while ensuring timely and compliant processing.Support remediation activities associated with audit findings, FDA observations, complaint backlogs, and quality system improvements.Investigation & Root Cause AnalysisConduct detailed investigations into product complaints, adverse events, and product performance issues.Partner with Manufacturing, Engineering, R&D, and Regulatory teams to determine root causes and appropriate corrective actions.Analyze complaint trends and quality data to identify recurring issues and opportunities for continuous improvement.Risk Assessment & FMEA SupportUtilize Process Failure Modes and Effects Analysis (PFMEA) and Design Failure Modes and Effects Analysis (DFMEA) methodologies to evaluate complaint-related risks.Assess the impact of complaints on product quality, patient safety, and regulatory compliance.Collaborate with cross-functional teams to update risk management documentation and support product risk evaluations.Manufacturing & Quality Systems SupportProvide quality engineering support for medical device manufacturing processes related to complaint investigations and product quality issues.Interface with production, supplier quality, and engineering teams to support containment actions and product evaluations.Ensure complaint remediation activities align with:FDA 21 CFR Part 820ISO 13485Internal Quality Management System (QMS) proceduresTraining & MentorshipTrain and mentor personnel on complaint handling processes, investigation techniques, documentation practices, and regulatory expectations.Promote best practices in complaint management, escalation, and post-market quality processes.Documentation & Regulatory ComplianceAuthor, review, and maintain complaint investigation records and associated quality documentation.Ensure records are accurate, complete, and inspection-ready to support regulatory audits and quality reviews.Assist during internal audits, external audits, FDA inspections, and remediation status reviews..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 product complaints within regulated medical device environments.Strong understanding of complaint handling systems, medical device manufacturing processes, and Quality Management Systems.Experience utilizing PFMEA and/or DFMEA methodologies.Working knowledge of:FDA 21 CFR Part 820ISO 13485Complaint handling and post-market surveillance processesStrong analytical, problem-solving, and technical writing skills.Excellent communication and cross-functional collaboration abilities.Preferred Qualifications:Experience in cardiovascular or Class II/Class III medical devices preferred.Prior remediation project experience supporting FDA commitments, Warning Letter responses, or complaint backlog remediation.ASQ Certified Quality Engineer (CQE) or similar certification preferred.Experience with electronic Quality Management Systems (eQMS).Key Competencies:Complaint Handling & InvestigationRoot Cause AnalysisPFMEA / DFMEA Risk AssessmentMedical Device Manufacturing SupportRegulatory ComplianceQuality Systems ExpertiseCross-Functional CollaborationTechnical DocumentationTraining & MentorshipContinuous Improvement.About BEPCBEPC 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!