Candidates from Hyderabad or willing to relocate to Hyderabad will be highly preferred

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 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





- 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, rapid-paced production environments

Pay: ₹1,200,000.00 - ₹2,000,000.00 per year

Work Location: In person

📌 Senior Quality Engineer - ISO 13485 (Medical/Manufacturing) (Hyderabad)
🏢 UpTye
📍 Hyderabad