Lead Quality Engineer

Lead Quality Engineer required to work within our QA team, based at our Global HQ in Cirencester, Gloucestershire.

Do you have a mechanical or biomedical engineering degree, time served experience within a quality assurance role in orthopaedic/medical devices or arthroplasty, and experience in the use of statistical and other quality tools for investigation processes? Corin are looking for an experienced Quality Engineer to join our high-performing team, working in a fast-paced, agile environment. You will be responsible for continually meeting all quality assurance requirements and provide exemplary quality engineering support.

Corin is a medical device business with innovative robotically assisted platforms for joint replacement surgery. We offer a unique combination of clinically proven hip & knee solutions and world leading technologies. Our OMNIBotics & OPS systems utilize intelligent instrumentation to give surgeons the ability to perform patient-specific procedures with high accuracy, with more consistent results and improved recovery rates.

The key responsibilities for a 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 of 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, develop and lead this training.
• Lead meetings and communications to ensure the proper functioning of the Quality Management System. Adapt their approach and leadership behaviour depending on the circumstances.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements.
• Responsible for monitoring Departmental metrics including on time trending and reporting, ensure Quality KPl's 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, analyse the data for the reasons of Quality Improvement and reporting. Provide support and training to ensure adherence with Carin's Standard Operating Procedures (SOP's) and Global Objectives for timeliness.
• Actively participate in Management Review, change control and compliance meetings as required.
• Experienced in use of statistical and other quality tools for investigation processes, Risk Management and Root Cause Analysis.
• Lead and/or support Internal Audit program, ensuring schedule adherence and auditing
• 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 cause, 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 Carin's Good Manufacturing Practice (GMP) and Good Documentation Practice (GDocP) as per ISO13485 & FDA21 CFR Part 820.
• Act as delegate for Quality Manager 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, 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.

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

• Influencing and leading: Develop a network of internal resources to facilitate completion of tasks. Individual influence is exerted at peer and manager level.
• Planning and organising: Complete daily work to meet established target dates with minimal guidance from supervisor. Independently manage complex tasks, effectively prioritise workload.
• Driving decision making and making an impact: Exercise authority within pre-established limits and approval, be an independent decision maker. Failure to achieve results may effect on schedules and programs.

The ideal QA Lead Quality Engineer will:

• Extensive experience of participating in internal and external audits (e.g., FDA, Notified Body, Supplier)
• Have worked within a highly regulated medical devise or pharma business (or similarly regulated business).
• Have experience with CAPA's, Quality, Root Cause analysis, NCR's, Change Control, Engineering, Quality Assurance, Risk Management and Statistical/Quality tools.
• Hold a BSc or MSc or HNC / HND (or equivalent) in an Engineering or related discipline - mechanical or biomedical ideally
• Extensive experience in a similar Quality Assurance role.
• Strong project management, organisational and time management skills.
• Good level of problem-solving skills, resolves issues through negotiation and internal/external influencing skills.
• Have six sigma, lean manufacturing and/or continuous improvement certification
• Driving Licence
• Must possess excellent communication skills.