About the role:
We are looking for a quality manager to guide our medical device developments. This role will focus on device development and regulatory submission and certification, providing strategies for driving product quality and continuous improvement.
Main duties and responsibilities:
- Liaising and co-operating with Certification and Notified Bodies, working with external consultants as required
- QMS documentation and development, ensuring the QMS meets the current needs of the business, in line with industry standards and accreditation requirements
- Managing internal, external and supplier audits e.g. recruiting and training of internal auditors
- Working with Engineering and other teams to ensure compliance with design and change control processes, providing QA oversight to development projects
- Supporting device development activities such as compiling and managing technical files
- Developing risk management plans and activities
- Establishing and managing the quality processes, e.g. change control, CAPA, document control, supplier evaluation, post-market surveillance
- Preparing for and supporting clinical trial submissions
- Quality training throughout the business including inductions, QMS, quality processes, standards, regulations etc.
- Responsible for ensuring that any changes to standards or regulations are identified and communicated in a timely manner
- Primary interface for external auditors and regulatory agencies for on-site audits and follow-up.
Essential skills and qualifications:
- Quality and product development experience within a medical device environment
- Knowledge and understanding of designing and testing products in accordance with applicable industry standards and regulatory requirements e.g. ISO 13485, EU Medical Device Regulation (MDR)
- Experience of using a formal, version-controlled document management system in a QA context
- Strong ability to effectively engage and influence stakeholders (i.e. operations, engineering, management, etc.)
- Highly organized, pro-active and self-motivated team leader
- Flexible rather than autocratic approach
- Degree Level in Engineering / Science / Technology or equivalent experience
- Ability to work autonomously and complete tasks under tight deadlines
- Good English Language skills. Appropriate UK qualification or SELT pass at B1 CEFR scale or confirmed Ecctis for degrees taught in English.
Desired skills and qualifications:
- A quality related CPD log showing formal training and development activities related to ISO standards and European Directives
- Strong knowledge of ISO 13485 & 21 CFR part 820
- Experience in leading an SME through ISO 13485:2016 transition, initial certification, or similar
- Knowledge of risk management planning and analysis (Hazard analysis, DFMEA etc.)
We offer a competitive Salary, dependent on experience, and company share options.
Other benefits include:
- Hybrid working (office and remote) and flexible hours (outside of core hours)
- Healthcare and Dental insurance
- Enhanced Pension scheme
- A variety of well-being initiatives (incl. gym membership contribution, cycle maintenance scheme)
- Financial support for commuters through our season ticket loan scheme
- Great central Cambridge location with excellent transport links (incl. rail, bus, bike, scooters) and local amenities
BIOS is committed to equal employment opportunities. We welcome applications from all qualified applicants who will receive equal treatment regardless of age, disability, gender reassignment, marital or civil partner status, pregnancy or maternity, race, nationality, ethnic or national origin, religion or belief, gender or sexual orientation.