Supplier Quality Engineer

ZEISS India; Bengaluru; On-site; INR 2,000,000 - 3,200,000; Full time

Job summary

ZEISS India is seeking a senior supplier quality professional to support quality excellence across medical device components and services. The role involves coordinating supplier qualification programs, audits, and CAPA processes while ensuring compliance with ISO 9001/13485 and regulatory requirements.

You will collaborate with R&D, manufacturing, and supply chain teams, travel up to 40% to supplier sites, and work across multiple locations in Bengaluru.

Qualifications

• Bachelor's degree in engineering is required.
• Experience with supplier quality in medical devices (class 1/2).
• ISO 9001/13485, MDSAP, EU-MDR knowledge is preferred.

Responsibilities

• Supplier Qualification Process: Prepare, execute and follow-up qualification as per business need.
• Supplier Audit: Report audit results, close findings on time, maintain audit plans.
• CAPA/SCAR: Drive CAPA for supplier quality with effectiveness check and closures.
• Supplier Performance Monitoring: Track supplier performance monthly for Vision Care System BU.
• External & Internal SQM/ Purchasing Audit: Participates in audits to ensure 100% compliance.
• Maintain local/global ASL of VCS suppliers.

Skills

APQP

NPI management

Supplier Audit

CAPA/SCAR

Quality systems

Regulatory affairs

Power BI

Global suppliers

Travel readiness

Communication

Education

Bachelor's degree in engineering

Tools

Power BI

Job description

This job role is responsible for supporting quality assurance efforts across business operations to ensure adherence to standards and enhance overall performance. They conduct quality assessments, analyze process efficiencies, and implement best practices to identify and resolve quality issues. They collaborate with cross-functional teams to support quality excellence, foster a culture of quality awareness, and align quality initiatives with organizational goals.

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.

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
• Analytical skills, Data Management, Experience in Power BI will be preferred.
• 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 to supplier locations and Zeiss Business entity as per business need (minimum - 40% travel).