Job description
Our client, a leading manufacturer in the medical device sector, seeks a meticulous Quality Control Specialist to uphold product quality and regulatory compliance. This role offers a clear path to impact, with cross-functional collaboration across Production, Engineering, and Supply Chain.
Join a dynamic team focused on precision, data-driven decision making, and continuous improvement. You will contribute to Quality Management System (QMS) activities, supplier quality, and problem-solving across the product lifecycle.
Responsibility
- Perform incoming, in-process, and final product inspections to verify conformance with specifications and drawings.
- Document non-conformances, investigate root causes, and coordinate CAPA activities with cross-functional teams.
- Support validation and change control processes, ensuring traceability and compliance with GMP/ISO standards.
- Maintain accurate inspection records, control plans, and quality metrics dashboards for leadership review.
- Participate in internal audits and supplier quality audits, driving corrective actions and continuous improvement.
- Utilize measurement tools (calipers, micrometers, CMM) and statistical methods to monitor process capability (SPC).
- Collaborate with Production to implement process improvements that enhance yield, reduce waste, and improve product reliability.
Qualification
- Bachelor's degree in Engineering, Chemistry, Biomedical, or a related field.
- 2+ years of Quality Control experience in manufacturing or pharmaceutical settings with GMP/ISO familiarity.
- Strong knowledge of SPC, CAPA, root cause analysis, and documentation control.
- Proficient with measurement tools and basic laboratory equipment; ability to interpret technical drawings and specs.
- Excellent problem-solving, communication, and cross-functional collaboration skills.
- Familiarity with QMS, SOPs, non-conformance investigations, and audit readiness.
- Lean manufacturing awareness and continuous improvement mindset; Six Sigma or related certification is a plus.