QMS Engineer

Responsibilities:

1.1   QMS Implementation & Maintenance

• Develop, document, and improve QMS processes, policies, and procedures.
• Ensure compliance with [ISO 9001/IATF 16949/ISO 13485/etc], customer standards, and regulatory requirements.
• Manage QMS documentation (quality manuals, procedures, SOPs, SIPs, work instructions).
• Manage technical documents/drawings

 1.2    Audits & Compliance

• Lead internal audits & 3rd party audits and support external/customer audits. The internal audit includes system audit, process audit & product audit.

• Coordinate corrective/preventive actions (CAPA) and track non-conformities.

• Prepare for and facilitate certification/surveillance audits.

 1.3    Continuous Improvement

• Collect and analyze quality data (KPIs, customer complaints, non-conformities, etc) to identify trends.

• Drive root cause analysis (RCA) and process improvements (e.g., Lean/Six Sigma).

• Train employees on QMS requirements and best practices.

 1.4   Cross-Functional Collaboration

• Work with Production, Engineering, and Supply Chain to resolve quality issues.

• Support risk management (e.g., FMEA) and change control processes.

Requirements:

• Strong knowledge of ISO standards and regulatory requirements (e.g., FDA, IATF).

• Expertise in auditing, CAPA, and RCA methodologies

• Analytical skills (e.g., statistical process control, SPC)

• Excellent communication and training skills.

• Knowledge of APQP, PPAP, or MSA (for manufacturing roles).

• Bachelor’s degree in engineering, Quality Management, or related field.

• At least 2 years of experience in QMS implementation/auditing.

• Certification in ISO 9001 Lead Auditor or equivalent (preferred).