Quality Assurance Specialist

9 hours ago

Liverpool, United Kingdom Wynne Consulting Full time

This range is provided by Wynne Consulting. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range Direct message the job poster from Wynne Consulting EMEA Senior Consultant - Power & Energy and Life Science at Wynne Consulting | moshp@wynneconsulting.co.uk | 07411 509 220 Job Description: Quality Assurance Officer (Must be eligible to work in the UK - Sponsorship not provided). Location: Liverpool, UK. Reporting To: Head of Quality & Regulatory Affairs Role Summary The Quality Affairs Officer is a crucial dual role responsible for ensuring the company's compliance with all applicable UK and international medical device regulations, primarily the UK Medical Devices Regulations (UK MDR) and the EU Medical Device Regulation (MDR, 2017/745). The QA Officer will manage day-to-day Quality Management System (QMS) activities and support regulatory compliance and submissions, ensuring our range of products – both sterile and non-sterile are safe and compliant for market access. Key Responsibilities Quality Management System (QMS) Compliance Documentation Control: Maintain, update, and control all QMS documentation in accordance with ISO 13485:2016 requirements. Internal Auditing: Plan and execute internal audits to schedule, identifying non-conformities and tracking Corrective and Preventive Actions (CAPAs). CAPA & NCR Management: Lead the Non-Conformance Report (NCR) and CAPA processes, ensuring thorough investigation, root cause analysis, and effective closure. Supplier Management: Assist in qualifying and auditing suppliers, maintaining the Approved Supplier List and ensuring supplier quality agreements are in place. Training: Develop and deliver QMS and regulatory training programs for personnel Skills, Experience & Qualifications (Essential) Category Requirement Education: Bachelor's degree in a relevant scientific, engineering, or life science discipline. Experience: Minimum 2-3 years of direct experience in Quality Assurance within the medical device industry. QMS Knowledge: Proven working knowledge and practical application of the requirements of ISO 13485:2016. Auditing Skills: Qualified Internal QMS Auditor (ISO 13485). Core Skills: Excellent technical writing, effective communication, documentation control, and attention to detail. Problem Solving: Proven ability to perform effective root cause analysis and manage the CAPA process. Category Requirement Product Expertise: Direct experience with sterile and non-sterile First Aid and other wound management devices (ranging from class 1 to class IIb). Specialized Standards: Practical knowledge of key supporting standards, including ISO 14971 (Risk Management) and ISO 10993 (Biocompatibility). System Tools: Familiarity with electronic Quality Management Systems (eQMS) software. Professional Body: Membership or certification from a professional regulatory body (e.g., RAPS, CQI, ASQ, TOPRA). Seniority level Associate Employment type Full-time Job function Quality Assurance Industries Medical Equipment Manufacturing Hospitals and Health Care #J-18808-Ljbffr

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