Quality Superintendent

About the role

Biomerics is seeking a Quality Superintendent to lead its quality engineering team in a highly regulated medical device environment. You will ensure compliance with quality policies, drive continuous improvement, and support customer‑related activities across multiple product lines.

Key responsibilities

• Supervise quality engineers and technicians in assigned areas, providing training and development.
• Participate in validations, transfers, changes, complaints, CAPAs, SCARs, and improvement projects.
• Maintain product acceptance criteria according to drawings and specifications.
• Escalate process or product risks promptly to the Quality Director.
• Oversee creation and approval of PPAPs.
• Analyze and improve quality systems (MRB, scrap rates, QITs/Kaizen, process metrics).
• Ensure the quality system complies with ISO 9001, ISO 13485, 21 CFR Part 820, and GMP.

Required profile

• Bachelor’s degree in Engineering (Industrial, Mechanical, Biomedical, Chemical, Manufacturing) or related field; Master’s in Quality Management preferred.
• Minimum 5 years of quality experience in the medical device industry, leading technical quality teams.
• Advanced English (B2‑C1) for client meetings and international audits.
• Relevant certifications such as CQE, Six Sigma Green Belt or Black Belt, ISO 13485 Lead Auditor, or ASQ credentials.

Required skills

• CQE certification
• Six Sigma Green Belt or Black Belt
• ISO 13485 Lead Auditor
• ASQ certifications
• Knowledge of ISO 9001, ISO 13485, 21 CFR Part 820, Good Manufacturing Practices