Senior Quality Engineer - ISO 13485 (Medical/Manufacturing)

Role Overview:

We are seeking an experienced Senior Quality Engineer with a strong background in ISO 13485 QMS implementation, CAPA management, supplier quality, validation and audit readiness. The ideal candidate must be someone with hands-on shop floor experience in a regulated manufacturing environment, preferably involving injection moulding, silicone moulding or precision component manufacturing.

The role demands someone who is practical, execution-driven, and highly knowledgeable about manufacturing processes, not just documentation.

Certifications and real manufacturing exposure are non-negotiable requirements.

The candidate should be able to independently manage, maintain and continuously improve a compliant ISO 13485 Quality System with end-to-end ownership.

Key Responsibilities:

Quality System & Compliance

• Maintain and improve the companys ISO 13485-compliant QMS, ensuring documentation control, change management, and risk analysis meet regulatory expectations.
• Lead internal audits, management reviews, and support external audits (ISO registrar and customer).
• Ensure compliance with ISO standards and customer-specific requirements.
• Develop, revise, and approve quality procedures, forms, and records.

CAPA & Non-Conformance Management

• Lead investigations for non-conformances, complaints and deviations using RCA tools (5 Whys, Fishbone etc.).
• Initiate & manage CAPA until closure with verification for recurrence prevention.
• Trend quality data & drive continuous improvement using SPC & Lean/Six Sigma tools.

Validation & Process Qualification

• Author/review IQ/OQ/PQ protocols & reports for processes, equipment & products.
• Support validation planning aligned with ISO 13485 expectations.
• Work closely with engineering to ensure smooth design transfer to production.

Supplier Quality

• Support supplier qualification, audits and performance monitoring.
• Review CoAs, conduct supplier risk assessments and manage SCAR actions.
• Maintain supplier files ensuring incoming material compliance.

Measurement, Inspection & Calibration

• Support inspection planning, AQL sampling, FAI documentation.
• Ensure calibration control, MSA studies (Gauge R&R) & metrology readiness.
• Interpret GD&T on drawings and guide inspectors when required.

Documentation & Reporting

• Maintain validation summary reports, PFMEA, Control Plans, PPAP & audit documentation.
• Generate quality metrics & dashboards for management.
• Train operators/engineers/inspectors on QMS processes and documentation.

Qualifications & Required Skills:

Education

• Bachelors degree in engineering, Quality or relevant technical domain.

Experience

• Minimum 8+ years in Quality Engineering in a regulated manufacturing environment.
• Proven expertise in ISO 13485 implementation, audit preparation, CAPA & risk management.
• Hands-on manufacturing floor experience is mandatory.
• Experience with injection moulding/silicone/plastics preferred.

Technical Skills

• ISO 13485 / ISO 9001 QMS implementation & maintenance
• CAPA, Non-conformance investigation & RCA (5 Whys/Fishbone)
• IQ/OQ/PQ validation documentation & execution
• Supplier audits, qualification & SCAR management
• AQL, FAI, GD&T interpretation, Calibration, MSA/Gauge R&R
• SPC, statistical tools, Minitab / DOE / control charts
• QMS & document control systems, ERP familiarity

Certifications Mandatory / Non-Negotiable

• ASQ CQE / CQA / Six Sigma Green/Black Belt required

Soft & Behavioural Skills

• Strong documentation accuracy & analytical capability
• Excellent cross-functional communication
• Ability to work independently & ensure quality ownership
• Detail-oriented with audit-ready mindset

Performance Metrics

• CAPA closure timelines and recurrence elimination
• Audit readiness and minimal non-conformities
• Reduction in defects/complaints
• Quality documentation compliance & on-time validations

Ideal Fit

• Someone who knows the manufacturing floor deeply, not only paperwork
• Can run Quality autonomously end-to-end, comfortable with high-mix, fast-paced production environments