Senior Quality Engineer – ISO 13485

Role Overview: We are seeking an experiencedSenior Quality Engineerwith a strong background inISO 13485 QMS implementation, CAPA management, supplier quality, validation and audit readiness . The ideal candidate must be someone withhands-on shop floor experiencein a regulated manufacturing environment, preferably involvinginjection moulding, silicone moulding or precision component manufacturing . The role demands someone who ispractical, 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 toindependently manage, maintain and continuously improve a compliant ISO 13485 Quality Systemwith end-to-end ownership.Key Responsibilities: Quality System & Compliance Maintain and improve the company’s 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 Bachelor’s degree in engineering, Quality or relevant technical domain. Experience Minimum8+ years in Quality Engineeringin a regulated manufacturing environment. Proven expertise inISO 13485 implementation, audit preparation, CAPA & risk management . Hands-on manufacturing floor experience is mandatory. Experience withinjection moulding/silicone/plasticspreferred. 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 whoknows the manufacturing floor deeply , not only paperwork Can run Quality autonomously end-to-end, comfortable with high-mix, fast-paced production environments