Senior Manufacturing QA Engineer

Position Summary
We are seeking a detail-oriented and proactive Senior Manufacturing QA Engineer to support product manufacturing quality across internal processes and external suppliers, including our contract manufacturer. You will be responsible for ensuring compliance with regulatory requirements, maintaining product quality, and supporting continuous improvement activities as we scale up production.
This role is critical to sustaining a high standard of quality and regulatory compliance as we grow our commercial presence in the medical device market.


Key Responsibilities
Manufacturing Quality Oversight

• Provide QA oversight for electronic and system-level manufacturing at the contract manufacturer.
• Monitor and analyze production quality metrics (e.g., FPY, defect trends, non-conformances).
• Support inspections, sampling plans, and lot release activities.

Non-Conformance & CAPA Management

• Lead root cause investigations and manage resolution of product and process non-conformances.
• Develop and implement corrective and preventive actions in collaboration with CM and internal teams.
• Track and report CAPA effectiveness and closure.

Process Validation & Documentation

• Support or lead quality aspects of process validations (IQ/OQ/PQ).
• Review and approve manufacturing documentation including SOPs, work instructions, and validation protocols.
• Ensure proper change control for process and product changes (ECOs, deviations, etc.).

Supplier Quality Management

• Participate in supplier audits and manage supplier quality performance.
• Support the development of quality agreements with contract manufacturers and key suppliers.
• Ensure incoming inspection criteria and procedures are in place and effective.

Regulatory Compliance & Audit Readiness

• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable standards.
• Support internal and external audits, including notified body and regulatory inspections.
• Maintain GMP documentation and audit trails related to manufacturing activities.

Continuous Improvement

• Identify and implement process improvements to enhance product quality and reduce defects.
• Champion quality culture across the manufacturing value chain.
• Collaborate with R&D, Ops, and CM to drive design transfer improvements and production readiness.

Qualifications

• Bachelor’s degree in Engineering, Quality, or a scientific discipline.
• 3–7 years of experience in quality engineering or manufacturing quality within a medical device or regulated industry.
• Strong understanding of ISO 13485, FDA QSR, and related standards (e.g., ISO 14971, IEC 60601).
• Experience with process validation, non-conformance handling, and CAPA systems.
• Ability to interpret technical drawings, BOMs, and manufacturing documentation.
• Excellent written and verbal communication skills; detail-focused and process-driven.

Preferred Attributes

• Experience with contract manufacturing environments.
• Certified Quality Engineer (CQE), Six Sigma, or auditor qualifications are a plus.
• Hands-on experience with ERP, QMS, or eDMS tools (e.g., Greenlight Guru, MasterControl, etc.).
• Comfortable in a fast-moving, small-team environment with high visibility and impact.

For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose