Senior Quality Engineer - Supplier Quality / Supplier Management Remediation

Senior Quality Engineer

• Supplier Quality / Supplier Management Remediation at BEPC Inc.
• Business Excellence Professional Consulting Senior Quality Engineer
• Supplier Quality / Supplier Management Remediation at BEPC Inc.
• Business Excellence Professional Consulting in Everett, Massachusetts Posted in about 16 hours ago.

Type:

full-time

Job Description:

BEPC is actively looking for Senior Quality Engineer

• Supplier Quality / Supplier Management Remediation, 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
• Supplier Quality / Supplier Management Remediation 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 Supplier Management remediation activities, including supplier quality assessments, supplier file remediation, supplier risk evaluations, audit review activities, and supplier corrective action management. The ideal candidate will possess strong experience in supplier quality engineering, supplier controls, and medical device Quality Management Systems within regulated manufacturing environments. This individual will work cross-functionally with Supplier Quality, Procurement, Manufacturing, Regulatory Affairs, and Operations teams to strengthen supplier oversight processes and ensure compliance with FDA and ISO requirements..

Summary of Duties and Responsibilities:

Supplier Management Remediation Lead and support remediation activities associated with Supplier Management files and supplier quality records. Review legacy supplier documentation to identify compliance gaps, incomplete records, and process deficiencies. Remediate supplier qualification, evaluation, and monitoring records to ensure compliance with internal procedures and regulatory requirements. Support supplier remediation activities related to audit findings, FDA observations, CAPAs, and quality system improvement initiatives. Supplier Risk Assessment & Critical Supplier Evaluation Evaluate and rank suppliers based on criticality, risk, product impact, and regulatory significance. Perform supplier risk assessments to determine appropriate qualification, monitoring, and oversight requirements. Collaborate with cross-functional teams to ensure supplier classifications align with business and regulatory expectations. Support ongoing supplier performance monitoring and risk mitigation activities. Supplier Audit Support Review supplier audit reports, findings, responses, and follow-up actions to ensure adequacy and compliance. Assess supplier audit effectiveness and identify areas requiring additional remediation or escalation. Support internal and external supplier audit activities as needed. Ensure supplier audit documentation is complete, accurate, and inspection-ready. Supplier Corrective Action Management Initiate, track, and remediate Supplier Corrective Action Requests/Reports (SCARs). Collaborate with suppliers and internal stakeholders to investigate supplier-related quality issues and determine root causes. Verify effectiveness of supplier corrective actions and ensure timely closure of SCAR activities. Support escalation and containment activities for supplier quality issues impacting manufacturing or product quality. Quality Systems & Manufacturing Support Provide supplier quality engineering support for medical device manufacturing operations and supply chain activities.

Ensure supplier controls align with:

FDA 21 CFR

Part 820 ISO 13485 Internal Supplier Quality Management requirements Support supplier-related activities involving: Incoming inspection Material quality issues Supplier change notifications Supplier performance trending Cross-Functional Collaboration Partner with Procurement, Manufacturing, Engineering, Regulatory Affairs, and Operations teams to support supplier quality initiatives and remediation timelines. Provide technical guidance regarding supplier compliance expectations and quality system requirements. Support change control and risk management activities related to supplier changes and supplier performance issues. Documentation & Compliance Author, review, and maintain supplier quality documentation and remediation deliverables. Ensure supplier records are accurate, complete, and audit-ready. Assist during internal audits, external audits, and FDA inspections involving supplier quality systems. Training & Mentorship Train and mentor personnel on Supplier Management processes, supplier risk assessment methodologies, and supplier corrective action procedures. Promote continuous improvement and best practices in supplier quality management.

Main Qualifications:

Education:

Bachelor's degree in Engineering, Quality, Life Sciences, or related technical discipline. 8+ years of Quality Engineering or Supplier Quality experience in the medical device industry. Demonstrated experience remediating Supplier Management files and supplier quality systems. Experience ranking and assessing critical suppliers within regulated manufacturing environments. Experience reviewing supplier audits and managing supplier corrective actions (SCARs). Strong understanding of supplier quality management processes and medical device manufacturing operations.

Working knowledge of:

FDA 21 CFR

Part 820 ISO 13485 Supplier Controls and Quality Systems requirements 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. Prior remediation project experience supporting FDA commitments, audit findings, or Warning Letter responses. ASQ Certified Quality Engineer (CQE), Certified Supplier Quality Professional (CSQP), or similar certification preferred. Experience with electronic Quality Management Systems (eQMS) and supplier management 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. ! 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!