Senior QA Design Officer

CAPU Search is proud to be working with our long-term partner Endomag, now part of the Hologic, to identify a Senior QA Design Officer (Micro) to support innovation and growth across their product portfolio.

Over the last decade, we’ve seen Endomag evolve from an academic research project into a global MedTech company. Their mission remains the same: to make breast cancer care more precise and less invasive.

Now used in over 1,350 hospitals across 45+ countries, and having helped over 500,000 women access better treatment, Endomag is entering an exciting new chapter following their acquisition by Hologic in 2024.

This is a great opportunity to join a purpose-driven team, play a key role in design control and product introduction, and help shape the future of QA within a business that’s still growing fast.

The purpose of the role:

The main function of this role will involve interacting with both Product Engineering and R&D, in introducing new products (the majority being sterile) and controlling design improvements to the existing portfolio to ensure the ongoing design review and release process is maintained as projects progress.

This role will also support the release process, of sub contract production devices, to ensure continued compliance of our existing portfolio. Which include class IIa, IIb and Class III sterile devices.

Other functions within this role will involve support functions, to the Quality and Regulatory team, Helping to maintain the companies Iso13485 quality system, liaising with various departments in a busy and dynamic environment

Key Responsibilities and duties:

• Implement and manage Design Control in regards to global Quality standards regulations and other requirements.
• Participate or manage the QA design meetings, reviews and release process ensuring that it maintains the requirement of ISO 13485;2016, regulatory requirements and our quality system.
• Assist with preparation of quality documentation as required for other worldwide territories eg FDA, TGA etc.
• Participate during audits by Notified Body or other organisations as required.
• Author/preparation of quality documentation as required for product introduction and improvement, including material and sterilisation controls ISO 10993, ISO11135, ISO11737.
• Documentation control to ensure implementation of changes to procedures, technical files within the QMS and technical files as standards evolve.
• Maintaining quality procedures across supply chain partners and manufacturers to ensure compliance to standards.
• Support the team to ensure quality audit actions are completed in a timely manner
• Ensure activities meet with and integrate with organisational requirements for health and safety, legal stipulations, environmental policies and general duty of care.

INDIVIDUAL SPECIFICATION

Qualifications

• Experience in Design and change control under ISO13485:2016 requirements is the major consideration
• Design and Development process knowledge and experience
• Previous experience working with eQMS systems
• Degree or equivalent in Microbiology /Molecular Biology or closely related field

Experience and Knowledge

• Minimum 5 years’ experience in ISO quality systems, ideally, sterile medical devices. or pharmaceuticals.
• Experience in Design and change control under ISO13485:2016 requirements is the major consideration
• Understanding and worked on risk assessments to ISO 14971:2019
• Design and Development process knowledge/experience around material and sterilisation compatibility processes. ISO 10993, ISO11135, ISO11737
• Evidence of experience working in a busy and demanding environment within a team and individually
• Good IT skills (MS Office) are required
• Experience eQMS systems is preferred
• Experience with validation.

Abilities and Skills

• Self-starter with strong motivational skills
• Good written skills, demonstrated in a range of contexts
• Evidence of effective communication and inter-personal skills
• Evidence of ability to work with critical attention to detail and high levels of accuracy
• Proven organisational and time management skills to effectively handle conflicting priorities and ensure tight deadlines are met
• Experience in working for a small, dynamic organisation

Other

Willingness to occasionally travel in UK and ROW