Senior Quality Engineer - Change Control Remediation

BEPC is actively looking for Senior Quality Engineer – Change Control 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 – Change Control Remediation (Medical Device / Cardiovascular) to join our client's site in the Boston, Massachusetts area. This role will support a critical remediation initiative within a cardiovascular medical device environment focused on the remediation, execution, and continuous improvement of Change Control processes to ensure compliance with regulatory requirements and internal Quality Management System (QMS) standards.The ideal candidate will possess strong experience managing change controls within regulated medical device manufacturing environments, including assessment of product, process, and system changes. This individual will work cross-functionally with Engineering, Manufacturing, Quality, Regulatory Affairs, and Operations teams to support compliant implementation of changes and remediation activities.Summary of Duties and Responsibilities:Change Control Remediation & ManagementLead and support remediation activities associated with legacy and ongoing Change Controls within a regulated medical device environment.Review existing Change Control records to identify compliance gaps, incomplete documentation, and process deficiencies.Drive Change Controls from initiation through approval, implementation, and closure while ensuring adherence to regulatory and internal quality requirements.Support remediation activities related to audit findings, FDA observations, CAPAs, and quality system improvement initiatives.Change Impact Assessment & Risk AnalysisEvaluate proposed changes for potential impact to:Product qualityPatient safetyManufacturing processesRegulatory complianceDesign and process validation activitiesUtilize risk management tools such as:PFMEA (Process Failure Modes and Effects Analysis)DFMEA (Design Failure Modes and Effects Analysis)Collaborate with cross-functional teams to assess and mitigate risks associated with process, product, supplier, and system changes.Manufacturing & Quality Systems SupportProvide quality engineering support for medical device manufacturing processes impacted by Change Controls.Ensure appropriate validation, verification, and implementation activities are identified and completed for manufacturing and quality system changes.Support updates to procedures, specifications, work instructions, and related quality documentation.Ensure Change Control activities align with:FDA 21 CFR Part 820ISO 13485Internal Quality Management System (QMS) requirementsCross-Functional CollaborationPartner with Engineering, Manufacturing, Regulatory Affairs, Supply Chain, and Quality teams to coordinate and execute change activities.Facilitate Change Control review meetings and provide technical guidance regarding quality and compliance impacts.Support timely implementation of approved changes while minimizing disruption to operations and product supply.Training & MentorshipTrain and mentor personnel on Change Control processes, risk assessment methodologies, and documentation expectations.Promote best practices in change management and quality system compliance across the organization.Documentation & ComplianceAuthor, review, and approve Change Control documentation to ensure records are complete, accurate, and audit-ready.Support internal audits, external audits, and regulatory inspections related to Change Control activities.Assist with metrics tracking, trending, and continuous improvement initiatives related to change management processes..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 Change Controls in regulated manufacturing environments.Strong understanding of medical device manufacturing processes and Quality Management Systems.Experience utilizing PFMEA and/or DFMEA methodologies for risk evaluation.Working knowledge of:FDA 21 CFR Part 820ISO 13485Change Control and document control processesStrong 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.Prior remediation project experience supporting FDA commitments, audit findings, or Warning Letter responses.ASQ Certified Quality Engineer (CQE) or similar certification preferred.Experience with electronic Quality Management Systems (eQMS) and Change Control systems.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!