Senior QA/QC Engineer

Overview

Experience: 5.00 + years

Salary: Confidential (based on experience)

Shift: (GMT+05:30) Asia/Kolkata (IST)

Opportunity Type: Hybrid (Chennai)

Placement Type: Full time Permanent Position

(*Note: This is a requirement for one of Uplers' client - Aletha Health)

What do you need for this opportunity?

Must have skills required:

Quality Control, Quality Assurance, ISO 13485, ISO 14971, ISO 2859-1, Polymer Testing

Aletha Health is Looking for:

Role Summary

We’re seeking a hands-on Senior QA/QC Engineer to build, run, and continually improve our medical device quality system, with a strong focus on plastic components and assemblies. You’ll own incoming/in-process/final quality, validation and test method rigor, supplier quality, and data-driven continuous improvement—while mentoring interns and junior engineers and partnering closely with Manufacturing, Design, and Supply Chain.

Added advantages: Medtech device startup experience; excellent drawing interpretation and GD&T; plastics/material science exposure, particularly biocompatible polymers and their manufacturing processes.

Key Responsibilities

• QMS & compliance: maintain and improve an ISO 13485-compliant QMS; apply ISO 14971 risk management; ensure alignment with FDA 21 CFR 820 and EU MDR documentation (DHF/DMR/DHR), CAPA, change control, and traceability.
• Inspection planning & execution: author inspection plans, control plans, and sampling using AQL (ISO 2859-1 / ANSI-ASQ Z1.4); drive FAI/PPAP as applicable; manage incoming, in-process, and final release inspections.
• Plastics quality focus: set cosmetic/functional acceptance criteria for injection-molded parts; review tool/part drawings for GD&T; analyze defects (sink, warp, flash, knit line, splay) and partner with suppliers on corrective actions.
• Metrology & TMV: lead dimensional verification via CMM/vision/gauges; conduct MSA/Gage R&R and Test Method Validation to ensure repeatability/reproducibility and accuracy.
• Process validation: plan and execute IQ/OQ/PQ for molding and downstream processes; establish SPC, control charts, and capability targets (Cp/Cpk).
• Biocompatibility & sterilization support: verify material certifications and lot traceability for medical-grade polymers; support ISO 10993 evidence collection; coordinate sterilization compatibility/validation (EtO, gamma, e-beam) and packaging validation (ISO 11607) when required.
• Supplier Quality: qualify and audit suppliers (per ISO 19011 principles), define CTQs, monitor DPPM/PPM, lead SCARs, and drive systemic improvements.
• Nonconformance & CAPA: lead NCR containment, root-cause analysis (5-Why, Ishikawa, 8D), implement corrective/preventive actions, and verify effectiveness.
• Calibration & EM: own IMTE calibration (traceable to ISO 17025), maintain status, and address OOT; support cleanroom/EM compliance (ISO 14644) if applicable.
• Documentation & training: write SOPs/WIs/forms; enforce Good Documentation Practices (GDP); train shop-floor teams, interns, and junior engineers on standards and problem-solving.
• Travel: regular domestic vendor visits and occasional overseas travel for audits, builds, and production ramps.
  
  
  

Required Qualifications

• Education: B.E./B.Tech in Mechanical, Manufacturing, Industrial, Plastics/Polymer, Biomedical, or related engineering; M.E./M.Tech preferred.
• Experience: 5+ years in QA/QC for medical devices or precision plastics manufacturing, including inspection planning, validations, and supplier quality.
• Standards & regulations: working knowledge of ISO 13485, ISO 14971, FDA 21 CFR 820, and EU MDR basics.
• Drawing & GD&T: strong reading of engineering drawings and ASME Y14.5; tolerance stack-up awareness.
• Statistics & tools: DOE basics, SPC, capability analysis, MSA/Gage R&R; proficiency with Minitab (or equivalent).
• Metrology: hands-on with CMM/vision systems, gauges, calibration systems, and report writing.
• Plastics & materials: familiarity with medical-grade, biocompatible polymers and quality implications of molding processes and sterilization.
• Soft skills: crisp technical writing, cross-functional communication, vendor management, and coaching mindset.
• Mobility: willingness to travel to meet vendors and travel overseas as needed.
  
  
  

Job location: Chennai, India

Reporting to: Head of Quality / Operations (or equivalent)

How to apply for this opportunity?

• Step 1: Click On Apply! And Register or Login on our portal.
• Step 2: Complete the Screening Form & Upload updated Resume
• Step 3: Increase your chances to get shortlisted & meet the client for the Interview!
  
  
  

About Uplers:

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(Note: There are many more opportunities apart from this on the portal. Depending on the assessments you clear, you can apply for them as well).

So, if you are ready for a new challenge, a great work environment, and an opportunity to take your career to the next level, don't hesitate to apply today. We are waiting for you!