Supplier Quality Engineer

Carl Zeiss India (Bangalore) Pvt. Ltd.; Bengaluru Urban; On-site; INR 2,200,000 - 3,500,000; Full time

Job summary

ZEISS India is seeking an experienced Senior Supplier Quality specialist to manage supplier qualification programs and audits across Vision Care and medical devices. The role emphasizes CAPA closure, supplier performance monitoring, and adherence to global quality standards.

Candidate should have 8+ years in supplier quality for medical devices, with ISO 9001/13485 and MDSAP exposure. Travel to supplier locations is expected as part of the role.

Qualifications

• Bachelor's degree in engineering (Mechanical/Bio Medical/Polymer).
• Minimum 8 years experience in supplier quality for medical devices (class 1/2).
• ISO 9001/13485, MDSAP, EU-MDR or related regulatory certifications preferred.

Responsibilities

• Supplier qualification: plan, execute and close qualifications per business need.
• Lead supplier audits; report findings and closure actions on time.
• Drive CAPA/SCAR efficiency with effective verification.
• Monitor supplier quality performance across Vision Care products monthly.
• Support NPI/APQP with R&D and Life Cycle Quality; ensure timely deliverables.

Skills

Supplier Quality

Audit & CAPA

APQP

8D/SCAR

Education

Engineering degree (Mechanical/Bio Medical/Polymer)

Tools

SPC

Root Cause Analysis

Power BI

Job description

ZEISS in India is headquartered in Bengaluru and present in the fields of Industrial Quality Solutions, Research Microscopy Solutions, Medical Technology, Vision Care and Sports & Cine Optics. ZEISS India has 3 production facilities, R&D center, Global IT services and about 40 Sales & Service offices in almost all Tier I and Tier II cities in India. With 2200+ employees and continued investments over 25 years in India, ZEISS’ success story in India is continuing at a rapid pace. Further information at ZEISS India.

Roles and Responsibilities

• Supplier Qualification Process: Prepare, execute and follow-up Supplier qualification as per business need
• Supplier Audit: Reporting of audit results and suggestion of appropriate actions, on time closure of audit findings, maintaining global and local audit plan.
• Supplier CAPA/SCAR issue resolution: Drive CAPA for supplier caused quality with effectiveness check and on-time closure.
• Supplier Performance Monitoring: Monitor supplier Performance of Vision Care System all BU on monthly basis
• Purchasing Control External & Internal Audit: Active participation in external and internal SQM/purchasing control audit and ensure 100% compliance.
• Approved Supplier List: Maintain local and global ASL of VCS business.
• Quality / Purchasing Agreement: Active participation in master purchasing agreement, quality agreement of suppliers.
• NPI & APQP: Work closely with R&D, Life Cycle Quality team on NPI projects, on-time NPI / APQP deliverables

Education

Bachelor's degree in engineering (Mechanical / Bio Medical / Polymer Engineering) qualification

Work Experience

Minimum 8 years of professional experience in a Supplier Quality of medical device (minimum class 1 and 2), lens, optical medical devices, optical frames and accessories, or regulatory industry. Experience in handling component, service, chemical, consumables, finished device contract manufacturer will be preferred.

Certification in ISO 9001 / ISO 13485, MDSAP, EU-MDR and other regulatory affairs will be preferred.

Other Skills

Experience in APQP, NPI project management, component/Parts & finished device development at supplier Experience in conducting and leading Supplier Audit, Audit NC closure, conducting audit at supplier (on-site / remote) Experience in handling supplier caused non-conformity, customer complaints, 8D, SCAR/CAPA must Experience in conducting process, special process, product audit at supplier. Experience in 5s/6s, P-FMEA, Control Plan, PFD, FAI, Packaging quality, PSW/PPAP documentation, GD&T must Experience in the field of control of outsourced processes such as plastic injection molding, screen printing, high-level assembly, sheet metal, casting, wiring harness, PCBA, off the shelf components will be added advantage. Experience in supplier qualification, maintaining global and local approved suppliers list Experience in 8D / CAPA, Problem Resolution, Process Validation (IQ,OQ,PQ), experience in ISO 13485 deployment, dealing with contract manufacturer, medical device classification, ISO 14971 Risk Assessment and Mitigation Experience in leading supplier performance monitoring, supplier development, process improvement will be preferred Experience in Statistical process control (SPC), Gage R&R / MSA must Certification in 6Sigma Yellow & Green belt & Lean will be preferred Experience in medical device process validation (IQ,OQ,PQ) methodology will be preferred. Experience in manufacturing transfer/localization, early supplier engagement will be preferred Experience in handling non-BOM suppliers such as service suppliers, transportation, warehouse, calibration supplier, test lab suppliers, repair centers, chemical and consumables suppliers will be preferred Certification is ISO 17025 will be preferred Experience in establishing Quality agreement with suppliers will be preferred Experience in good documentation practice will be preferred Experience in handling global suppliers of APAC / EMEA / NALA region.

Location & Business Travel

Candidate should work with multiple stakeholders and multiple locations of ZEISS Entity (Base Location - Electronic City & Devenhalli Bengaluru) Travel: Candidate should travel supplier locations and Zeiss Business entity as per business need (minimum - 40% travel) Specific Knowledge/Skills Knowledge in lens manufacturing industry is preferred. Knowledge in handling monomers, chemicals, resin, molds & other general consumables for lens is an added advantage. Knowledge in cleanroom environmental monitoring (ISO 14644), Familiarity with optical metrology equipment (refractometers, lens-meters, surface profile analyzers). Knowledge in managing shelf-life, storage, and cold-chain logistics for chemical monomers and polymers, resins are preferred. Expertise in national and international Medical Device standards and regulations, Regulation (EU) 2017/745, ISO 13485:2016, MDSAP, MPDG, Directive 93/42/EEC, etc. ISO 19011 Auditor certification is an advantage. Good communication, presentation and moderation skills must Global Perspective: Experience in handling global suppliers and global stakeholders is must. Ability to build and organize audit teams, auditee. Experience in internal/external certification ISO 9001/13485 audit specific to supplier quality and purchasing control Data driven problem solving & decision making skills Analytical skills, Data Management, Experience in Power BI will be preferred. Project Management Data-driven decision-making Fluent in English is mandatory. Fluency in German is an advantage.

Location: Candidate should work with multiple stakeholders and multiple locations (Electronic City & Devenhalli Bengaluru) Travel: Candidate should travel supplier locations and Zeiss Business entity as per business need (minimum - 40% travel)

Your ZEISS Recruiting Team

Itishree Pani Step out of your comfort zone, excel and redefine the limits of what is possible. That’s just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people. In a spacious modern setting full of opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long-term goal of the Carl Zeiss Foundation: to bring science and society into the future together. Join us today. Inspire people tomorrow.

Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.