Job Description
Join Mills Recruitment as a Quality Manager (Medical Industry) where you will lead and elevate ISO13485 quality standards across the full product lifecycle, ensuring compliance while driving continuous improvement. You will work closely with cross-functional teams to develop, implement, and maintain robust quality management systems that meet stringent regulatory requirements in the medical device sector. This role offers the opportunity to make a tangible impact on product safety and efficacy, fostering a culture of excellence and innovation.
In this position, you will be responsible for overseeing internal audits, managing corrective and preventive actions (CAPA), and coordinating with suppliers to ensure incoming material quality. You will also play a key role in training staff, monitoring key performance indicators, and leading improvement initiatives that reduce waste and enhance efficiency. If you are passionate about quality in the medical industry and thrive in a dynamic environment, we invite you to apply.
Responsibilities
- Develop and maintain ISO13485 compliant Quality Management System (QMS) processes.
- Plan, coordinate, and execute internal audits and manage audit findings.
- Oversee CAPA investigations, ensuring timely closure and effectiveness checks.
- Collaborate with R&D, production, and supply chain teams to embed quality at every stage.
- Monitor key quality metrics, prepare reports for management, and drive continuous improvement projects.
- Ensure supplier qualification and incoming material inspection meet regulatory standards.
- Provide training and guidance to staff on quality policies, procedures, and best practices.
- Stay updated on evolving medical device regulations and incorporate changes into QMS.
Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Quality Management, or related field.
- Minimum 5 years of experience in quality assurance/QC within the medical device or regulated manufacturing industry.
- Proven expertise with ISO13485, ISO 9001, and other relevant standards.
- Strong knowledge of CAPA, internal auditing, and risk management (ISO 14971).
- Excellent analytical skills with ability to interpret data and drive improvement initiatives.
- Effective communication and interpersonal skills, capable of influencing cross-functional teams.
- Proficiency in QMS software and Microsoft Office Suite.
- Professional certification such as CQA, CMQ/OE, or ASQ is a plus.