Quality Assurance Engineer

Position's Scope:

 The QA Engineer is responsible for ensuring that all quality assurance activities related to suppliers, materials, and internal processes comply with applicable regulatory and quality management system requirements. This includes management of supplier quality, handling of nonconforming materials, managing Material Review Board (MRB), and execution of the internal audit program. The role is critical in maintaining compliance with ISO 13485, FDA 21 CFR Part 820, and the company’s Quality Management System (QMS).

Main Responsibilities:

- Establish, maintain, and improve the Supplier Quality Program in alignment with regulatory and company requirements.

- Evaluate, qualify, and periodically re-evaluate suppliers and service providers.

- Maintain the Approved Supplier List (ASL).

- Review and approve supplier change notifications and Certificates of Conformance (CoC) or Analysis (CoA).

- Monitor supplier performance metrics (e.g., on-time delivery, quality issues, complaint rates) and drive corrective/preventive actions when needed.

- Perform supplier audits and ensure timely closure of supplier CAPAs.

- Serve as a core member of the MRB, facilitating review and disposition of nonconforming materials, components, and products.

- Lead or support investigations of Nonconforming Material Reports (NCMRs), including root cause analysis and risk assessment.

- Ensure proper documentation, traceability, and timely resolution of NCMs.

- Collaborate with manufacturing, engineering, and supply chain teams to prevent recurrence.

- Support scrap and rework process documentation and approval according to SOPs and regulatory requirements.

- Support external and regulatory audits (Notified Body, FDA, etc.) by providing records and objective evidence.

- Identify opportunities for continuous improvement in QMS processes.

- Maintain and update quality procedures, work instructions, and records related to supplier management, MRB, and internal audits.

- Support change control, CAPA, and document control processes.

- Participate in risk management, validation, and product lifecycle activities as needed.

- Support training and awareness programs related to quality system processes.

- Provide QA support for new supplier onboarding and change implementation.

Skills:

 - Excellent documentation, organizational, and communication skills.

- Ability to work cross-functionally with engineering, operations, and supply chain teams.

- Auditor certification (ISO 13485 Lead/Internal Auditor) preferred.

- Experience in supplier auditing or external quality assessments.

- Experience with CAPA systems and risk management tools.

Education:

Bachelor's degree in engineering (Biomedical, Mechanical, Industrial, Chemical) or related scientific discipline.

Relevant Experience:

 - 4–8 years of experience in Quality Assurance or Supplier Quality within the medical device or other regulated industry.

- Solid understanding of ISO 13485, FDA 21 CFR Part 820, ISO 14971, and GMP principles.

- Proven experience with supplier management, nonconformance handling, MRB activities, and internal audits.

Subordinate to:

QA Director