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Quality Assurance Project Lead
2 weeks ago
The Quality Engineering Team Lead oversees the Quality Engineering team, ensuring that all projects are managed in a structured fashion and completed in compliance with relevant procedures.
This role is responsible for driving quality initiatives, managing project activities, representing the team at key review meetings, and building effective relationships with other functions.
The Quality Engineering Team Lead will assess workload, allocate tasks accordingly, and report to the Quality Engineering Manager.
Key Responsibilities:
- Drive all assigned Quality Engineering projects.
- Manage project activities to ensure timely completion of milestones.
- Represent the team at key review meetings.
- Build effective relationships with other functions.
- Lead the area of FDA, QSR, and ISO13485 requirements.
- Identify and implement opportunities for improvement.
- Maintain a proactive approach to developing Cook's Quality system.
- Evaluate and address in-house or external Quality issues.
- Responsible for Quality systems, including Design, Process, and Software Validation, Supplier Quality, CAPA, Non-conformances, Customer Complaints, Internal Audit, Supplier Audit, and Regulatory Audit Programmes.
- Prepare, execute, and analyze Quality Engineering documentation.
- Trend and analyze key Quality metrics.
- Assess risk throughout Quality Engineering key processes and systems.
Required Skills and Qualifications:
- Third-level qualification in Science, Engineering, or a relevant technical discipline.
- Proven knowledge and experience (ideally 6 years) of working with ISO13485, ISO14971, Medical Device Directive, EU Medical Device Regulation 2017/745, and FDA QSR, including 21 CFR Part 820 and 21 CFR Part 11, preferably gained in the medical device industry.
- Previous supervisory experience would be beneficial.
- Excellent communication and interpersonal skills.
- Proven track record of pursuing continuous self-improvement.
- Good working knowledge of Microsoft Office.
- Proven Problem-Solving Skills.
- Good working knowledge of statistics.
- Knowledge and experience of all aspects of validation.
- Excellent organisational, time management, and presentation skills.
- Excellent attention to detail.
- Proven self-starter.
- Willingness and availability to travel on company business.
