Senior Quality Engineer - CAPA Remediation

Senior Quality Engineer

• CAPA Remediation at BEPC Inc.
• Business Excellence Professional Consulting Senior Quality Engineer
• CAPA Remediation at BEPC Inc.
• Business Excellence Professional Consulting in Winthrop, Massachusetts Posted in 1 day ago.

Type:

full-time

Job Description:

BEPC is actively looking for Senior Quality Engineer

• CAPA 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
• CAPA Remediation to join our client's site in the Boston, Massachusetts area.

This role will support a high-priority remediation project within a cardiovascular medical device environment, with a strong focus on Corrective and Preventive Action (CAPA) activities including remediation, investigation, root cause analysis, corrective action implementation, and cross-functional quality system improvements. The ideal candidate will possess strong experience in medical device manufacturing, quality systems, and regulatory compliance, with demonstrated success leading CAPAs in regulated environments. This individual will collaborate cross-functionally with Quality, Manufacturing, Engineering, Regulatory Affairs, and Operations teams to ensure remediation activities are completed in accordance with FDA and ISO requirements.

Summary of Duties and Responsibilities:

CAPA Remediation & Execution Lead and support remediation activities associated with legacy and ongoing CAPAs within a medical device manufacturing environment. Review existing CAPA records to identify compliance gaps, deficiencies, and opportunities for process improvement. Drive CAPA activities from initiation through closure, ensuring timely execution and effectiveness verification. Support remediation efforts related to FDA observations, internal audits, external audits, and quality system assessments. Root Cause Investigation Conduct detailed root cause investigations using established problem-solving methodologies such as: 5 Why Analysis Fishbone/Ishikawa Diagrams Fault Tree Analysis Trend Analysis Analyze quality data, manufacturing deviations, complaints, and nonconformances to identify systemic issues. Partner with cross-functional teams to ensure investigations are technically sound and properly documented. Corrective & Preventive Actions Develop, implement, and verify corrective and preventive actions to address identified root causes. Ensure corrective actions are sustainable, measurable, and compliant with applicable regulatory requirements. Monitor CAPA effectiveness and support continuous improvement initiatives across the Quality Management System (QMS). Quality Systems & Compliance Support compliance with:

FDA 21 CFR

Part 820 ISO 13485 Internal Quality System procedures Interface with Manufacturing, Engineering, Supplier Quality, and Regulatory teams to ensure CAPA activities align with overall quality system requirements. Assist with updates or improvements to SOPs, work instructions, and CAPA procedures as necessary. Documentation & Reporting Author and review quality documentation related to CAPA activities, investigations, and remediation deliverables. Maintain accurate and audit-ready records to support regulatory inspections and internal quality reviews. Provide status updates and remediation progress reporting to project leadership and stakeholders. Training & Mentorship Provide guidance and training to personnel on CAPA processes, root cause methodologies, and quality system expectations. Mentor junior quality engineers and cross-functional team members on remediation best practices.

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 CAPAs in regulated environments. Strong understanding of medical device manufacturing processes and Quality Management Systems. Experience performing root cause analysis and implementing corrective actions.

Working knowledge of:

FDA 21 CFR

Part 820 ISO 13485 CAPA systems and quality processes Strong technical writing and documentation 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 activities. ASQ Certified Quality Engineer (CQE) or similar certification preferred. Experience with electronic quality management systems (eQMS). 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!