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 opportunityMust have skills required:Quality Control, Quality Assurance, ISO 13485, ISO 14971, ISO 2859-1, Polymer TestingAletha 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 improvementwhile 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)
