Key Responsibilities Quality Operations Support Provide day?to?day quality engineering support to manufacturing and operations teams.
Lead investigations, root?cause analysis, and implementation of corrective & preventive actions (CAPA).
Support incoming inspection, in?process quality checks, and final product release activities.
Maintain and improve production documentation, including procedures, work instructions, and inspection plans.
Regulatory & Compliance Ensure compliance with ISO 13485, FDA 21 CFR Part 820, MDR, and other relevant standards.
Lead internal audits and support external audits by notified bodies and regulatory authorities.
Maintain risk management documentation (e.g., PFMEA, DFMEA, hazard analyses).
Support change control, deviation management, and quality?system improvements.
Manufacturing & Process Support Partner with Engineering and Operations to drive process validation (IQ/OQ/PQ) and equipment qualification.
Lead quality oversight for new product introduction, scale?up, and continuous improvement projects.
Monitor and trend key quality and process KPIs, identifying opportunities for operational improvements.
Lead supplier quality activities, including qualifications, audits, and material performance investigations.
Collaboration & Cross?Functional Leadership Work closely with R&D during design transfer to ensure smooth transition into manufacturing.
Provide quality guidance to manufacturing technicians and engineers.
Support documentation creation for technical files and regulatory submissions.
Represent the Quality function in cross?functional meetings and project reviews.
Qualifications & Experience Bachelor's or Master's degree in Engineering, Quality, Biomedical, Mechanical, or a related discipline.
5+ years experience in Quality Engineering, ideally within the medical device or other regulated industry.
Strong understanding of ISO 13485, FDA 21 CFR 820, and risk?management frameworks.
Experience in operations?focused quality engineering, including CAPA, non?conformance management, validation, and supplier quality.
Demonstrated experience supporting manufacturing scale?up in a fast?paced environment.
Excellent analytical, communication, and problem?solving skills.
Ability to lead investigations, influence cross?functional teams, and drive improvements independently.
What We Offer Opportunity to join an innovative, rapidly growing organisation developing life?changing technology.
A collaborative and mission?driven work environment.
Career progression and the chance to shape quality systems at a pivotal stage of growth.
Competitive compensation and a comprehensive benefits package.
At Wallace Myers International Recruitment Agency we specialise in sourcing professionals for key industries and services.
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For more info see Skills: Quality Assurance Quality Operations Design Control medical device