Lead Quality Assurance Engineer

2 weeks ago

Cirencester, United Kingdom Corin Group Full time

Corin seeks a Lead Quality Assurance Engineer (known as a QA Lead Quality Engineer internally) to provide exemplary quality engineering support and be a QA ambassador within our medical device business, where we design, manufacture, inspect, and distribute hip and knee implants. This is an onsite role based in Cirencester, Gloucestershire.


As a QA Lead Quality Engineer, you will be accountable in

:Influencing and leading: Develop a network of internal resources to facilitate the completion of QA tasks. Individual influence is exerted at the peer and manager level

.Planning and organizing: Complete daily work to meet established QA target dates with minimal guidance from the supervisor. Independently manage complex tasks, and effectively prioritize workload

.Driving decision-making and making an impact: Exercise authority within pre‐established limits and approval and be an independent decision-maker. Failure to achieve results may affect schedules and programs


The ideal QA Lead Quality Engineer will have/b

  • A BSc or MSc or HNC / HND (or equivalent) in an Engineering or related discipline - mechanical or biomedical ideally
  • Extensive experience of participating in internal and external audits (e.g., FDA, Notified Body, Supplier)
  • Worked within a highly regulated business (EG -medical device, pharma business, or healthcare ideally)
  • Experience with CAPAs, Quality, Root Cause Analysis, NCRs, Change Control, Engineering, Quality Assurance, Risk Management, and Statistical/Quality tool
  • Extensive experience in a similar Quality Assurance role
  • Strong project management, organizational, and time management skill
  • Problem-solving skills, resolving issues through negotiation, and internal/external influencing skills
  • Six Sigma, lean manufacturing, and/or continuous improvement certification
  • Excellent communication skills


Corin offers great benefits including

  • Competitive salary
  • Pension starts at 6% rising to 9.7% after 18 months if you contribute
  • 4%
  • Life assurance 6x basic salary
  • BUPA medical

The key responsibilities of a QA Lead Quality Engineer are to

  • Utilise a detailed knowledge of relevant quality standards and regulations (in particular FDA, ISO, and MDR) to support their application and implementation across the Company.Evaluate the compliance
  • Manufacturing and Quality activities with relevant standards and regulations. Design, manage, and implement complex process solutions to improve workflow or compliance. Support and/or lead changes through the QMS change control system
  • Work with and influence key stakeholders to develop and maintain procedures and compliant documentation. Identify training opportunities and develop and lead this training
  • Lead meetings and communications to ensure the proper functioning of the Quality Management System. Adapt their approach and leadership behavior depending on the circumstances.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements
  • Monitor Departmental metrics including on-time trending and reporting, ensuring Quality KPIs and targets are met. Support others with QA data analysis, trending, and reporting
  • Manage non-conformance (NCR) and Corrective & Preventive Action (CAPA) processes as directed. Conduct and/or support data capture and root cause investigations, review actions for comprehensiveness, determine stock disposition, and analyze the data for the reasons of Quality Improvement and reporting. Provide support and training to ensure adherence with Corin’s Standard Operating Procedures (SOPs) and Global Objectives for timelines
  • Actively participate in Management Review, change control, and compliance meetings as required.
  • Experienced in the use of statistical and other quality tools for investigation processes, Risk Management, and Root Cause Analysis
  • Lead and/or support the Internal Audit program, ensuring schedule adherence and auditing areas for compliance with applicable standards and regulations
  • Be proficient as a lead representative for presenting QA Systems to internal and external auditors. Support external audits as required
  • Support timely product complaint investigations: investigate root causes, evaluate risks, and determine appropriate corrective and/or preventative actions. Support the analysis of data for Quality Improvement and reporting
  • Adhere to Quality Management System (QMS) requirements in line with Corin’s Good Manufacturing Practice (GMP) and Good Documentation Practice (GDocP) as per ISO13485 & FDA21 CFR Part
  • 820.Act as delegate for Quality Management when required
  • Champion change management and lead continuous improvement
  • Review and escalate concerns, evaluating risks and benefits of available options
  • Supervise and mentor team members and provide support and coaching for both technical and soft skills. Provide direct and actionable feedback
  • Work under own initiative. Prioritise work to meet deadlines, escalate and delegate as required. Evaluate and balance stakeholder requirements
  • Always act with humility and integrity, be a role model for team members

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