- Established, growing Medical Device manufacturer
- Supportive multinational backing
- Beautiful Bay of Plenty setting
About the company:
Our client is a manufacturer of infection control, contamination control and hygiene products. Their market-leading products are sold globally and seen by their customers as broad spectrum sterilization technology surpassing outdated technologies offered by some of their competitors. The business has an office in Tauranga supporting their facilities in the UK.
As part of their continued focus on excellence, our client is looking for a dynamic and passionate Quality Assurance Manager to oversee the commitment to quality and compliance into the future.
About the role:
The QA Manager reports to the Managing Director and will work collaboratively with a talented group of Senior Managers, across the organisation to ensure quality and compliance remain a priority in this fast moving, high growth company.
With no direct reports, this role will have a broad range of responsibilities to keep you interested, starting with maintenance and evolution of their existing QMS and ensuring that all products manufactured and sent to market meet their ISO13485 standards. You’ll also manage and customer complaints, corrective actions, product release and document control.
You, the candidate:
As a preferred candidate, you will have a strong background in medical device or pharmaceutical quality assurance, ideally with some at leadership or management level, and a solid working knowledge of ISO13485 plus preferably ISO14971. You’ll be a self starter, autonomous in your work ethic and have the proven ability to build and maintain solid professional relationships.
Skills / Experience:
- Bachelor’s Degree in Science/ Engineering or related technical field
- 5-10 years experience in Regulatory and QA in a related regulated medical device or pharmaceutical environment is required
- Previous experience in developing, implementing and embedding Quality Systems in GMP regulated manufacturing environments working with ISO, GMP, FDA or other key regulatory bodies
- Demonstrated knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control etc)
- Internal auditing ISO13485 QMS experience (3+ years)
- Great project management skills
- Exceptional written and oral communication skills
Location and Culture:
This position is based in Tauranga in the beautiful Bay of Plenty. You will need to be prepared to work from this location if successful in your application. A small by friendly office environment will welcome you and support you as you develop in this role. With a production facility and offices in the UK, there will also be routine liaison with your colleagues over there.
For a confidential enquiry or to apply for this position please click on the APPLY button below, alternatively contact Tony De Barr on 04 472 6558 or email email@example.com