Senior QA/QC Engineer

Senior QA/QC Engineer (Medical Devices)

Experience:

Opportunity Type:

Placement Type:

Note: This is a requirement for one of Uplers' Clients Aletha Health:

Must have skills: Quality Control OR Quality Assurance AND Polymer Testing

About Aletha Health:

Aletha Health is dedicated to freeing individuals from pain caused by muscle tension through innovative, drug-free solutions. Our products offer effective alternatives to medication and invasive procedures, empowering users to achieve a pain-free life with simplicity and confidence.

Role summary

Were 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. Youll 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.

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