Quality Engineer

SMC Ltd; Bengaluru; On-site; INR 600,000 - 900,000; Full time

Job summary

A leading manufacturing firm in Bengaluru is seeking a Quality Assurance professional to oversee testing of raw and finished goods, maintain accurate records, and conduct inspections. Candidates should possess metrology skills and familiarity with ISO 13485 and ISO 9001 standards. Strong analytical and troubleshooting abilities are essential. This role is critical in ensuring product quality and compliance within the organization.

Qualifications

• Experience with metrology equipment such as VMS and CMM.
• Knowledge of ISO 13485 & ISO 9001 standards.
• Good technical and analytical skills.

Responsibilities

• Ensure testing of materials in line with SOPs.
• Maintain device history records and product release checklists.
• Conduct inspections at various stages of production.

Skills

Metrology equipment knowledge

Product & process validation

Analytical and troubleshooting skills

Tools

VMS

CMM

Minitab software

Job description

Key Accountabilities/Essential Functions

• To ensure Raw Material / Packing Material and finished goods testing in line with the SOPs.
• To maintain device history records (DHR) & product release checklist for each lot.
• To conduct inspections at in-process, in-coming and completes the final inspections.
• To prepare technical documents like DMR & DHR.
• To maintain microbial record in ISO class-7 & class-8 as per procedure.
• Creating master documents to track calibration & latest version of documents and records.
• To prepare control plan, FMEA & FAIR documents.
• To prepare 8D and supplier CAPA reports.
• Monitoring calibration activities.
• Perform metrology activities & drawing reviews.
• Coordinates investigation, root cause analysis & corrective action.

Technical/Functional Skill Sets

• Preferred skills in various metrology equipment, such as VMS, CMM programming, etc.
• Product & process validation requirements & implementation.
• Gauge R&R, CpK, PpK studies, IQ, OQ,PQ validation/qualification, MSA, run charts, etc.
• Working knowledge of the ISO 13485 & ISO 9001standards.
• FAIR inspection, DHR & control of documents.

Personal Qualities/Characteristics required for the position

Good technical, analytical and trouble shooting skills.

Equipment Used

• VMS, CMM, Vernier caliper, micrometer, height gauge, etc.
• Minitab software.

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