Our client is seeking a motivated and proactive individual to join their team as a Quality Manager. If you are passionate about maintaining and improving quality systems, this is the perfect opportunity for you!

As the Quality Manager, you will be responsible for the maintenance and coordination of the Quality Systems for our client's site. Your main purpose will be to ensure compliance with all relevant quality and regulatory standards. You will play a vital role in supporting the business and ensuring that it fulfils its obligations as a legal manufacturer of medical devices.

Your key responsibilities will include:

• Managing Quality Investigation Reports and deviations, along with developing and implementing CAPA plans.
• Conducting regular reviews of quality critical documents, systems, and procedures to identify and implement necessary changes.
• Maintaining and managing all quality critical documents, such as Quality manuals, SOPs, Quality Policies, and Audit Reports.
• Leading process improvement projects across the manufacturing site.
• Acting as the internal audit team leader.
• Supporting the Production, Warehouse, and Maintenance processes in maintaining quality standards and resolving any issues.
• Assisting production in high-risk routine validation activities, such as sterile manufacturing, C2C validation, and media fill.
• Reviewing and approving housekeeping, fabrication, and glass audits.
• Leading and supporting external audits from customers and regulatory authorities.
• Monitoring temperature on-site and ensuring equipment, processes, and new products are validated and verified.

To be successful in this role, you should have:

• A minimum of 3 years of experience in Quality Management within a regulated healthcare environment.
• Excellent understanding of regulations supporting healthcare product development, such as GMP, GDP, Medical Device, ISO 9001, and ISO 13485.
• Proactive problem-solving skills and the ability to work well in a team.
• Willingness to share your knowledge and experience with others.

Desirable qualifications and experience:

• Experience working in a cleanroom environment.
• Previous experience managing a team.

Our client values integrity, continuous improvement, teamwork, and being all on the same side. If you are looking for a company that aligns with these values and offers excellent opportunities for personal and professional growth, then this is the place for you!