Quality Assurance Manager
2 months ago
Job Title: Quality Manager
Location: Manchester, UK (On-site, with flexibility for 1 day remote per week)
Employment Type: Full-time, Permanent
About the Role:
Our client, a UK-based medical device company specialising in cardiovascular devices, is seeking an experienced Quality Manager to oversee quality compliance and lead the quality team at their Manchester site. This role is crucial for ensuring the highest standards in manufacturing, and distribution of life-saving cardiovascular products, maintaining compliance with ISO 13485, ISO 9001, and Good Distribution Practice (GDP) standards. The successful candidate will have a strong background in quality management within the medical device industry, particularly in cardiovascular products, and bring expertise in conducting audits, as well as building and leading high-performing teams.
Key Responsibilities:
- Lead site quality management activities to ensure compliance with ISO 13485, ISO 9001, and GDP standards for cardiovascular devices.
- Oversee quality assurance processes across the cardiovascular device supply chain, including supplier audits, risk assessments, and end-to-end compliance.
- Manage and conduct internal and external audits, regulatory inspections, and third-party assessments, ensuring that all cardiovascular products meet stringent quality and regulatory standards.
- Recruit, train, and lead the quality team, promoting a culture of quality excellence and continuous improvement.
- Support CAPA (Corrective and Preventive Action) activities, driving effective solutions and improvements.
- Collaborate closely with supply chain, manufacturing, and R&D teams to enhance quality processes for cardiovascular products throughout the product lifecycle.
- Provide quality-related training to staff, acting as the main point of contact for all quality-related enquiries and issue resolution.
Qualifications:
- Bachelor’s degree in Quality Management, Engineering, or a related discipline; advanced qualifications are a plus.
- Minimum of 5 years’ experience in quality management within the medical device industry, with a preference for cardiovascular device experience.
- Comprehensive understanding of ISO 13485, ISO 9001, and GDP requirements for medical devices.
- Proven experience in conducting internal and external audits, with a strong understanding of audit processes and regulatory expectations.
- Proven experience in hiring, training, and leading teams to meet quality performance goals.
- Strong analytical and problem-solving skills, with a hands-on, results-oriented approach.
- Excellent communication and leadership skills, with the ability to collaborate across departments.
Perks and Benefits:
- Competitive salary with performance-based bonuses.
- Company car for both business and personal use.
- 30 days of paid annual leave plus bank holidays.
- Flexible working options, with potential for one remote workday per week after the initial period.
- Opportunities for career advancement and professional development
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