Lead Quality Assurance Professional
1 day ago
The Lead Quality Assurance Professional plays a pivotal role in ensuring the development, manufacture and commercialisation of medical devices meets user, regulatory and ISO 13485 requirements.
Key Responsibilities:- Provide quality support during in-house manufacture and lot release.
- Develop quality plans, programs and procedures for commercialisation.
- Ensure all work is carried out in compliance with Quality, Regulatory and company policies and systems.
- Review, analyse and report on quality discrepancies related to product design and manufacture.
- Bachelor's degree in a relevant Engineering or Science field.
- 5 years' experience in the medical device industry or equivalent higher-level postgraduate study (masters or PhD).
- Strong understanding of engineering fundamentals, project planning, communication and writing skills.
- Knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820) essential.
This role requires strong analytical and problem-solving skills, as well as excellent communication and collaboration abilities. The successful candidate will be motivated, flexible and able to thrive in a fast-paced environment.
Our Ideal Candidate: If you possess a solid foundation in quality assurance principles, are comfortable working in a dynamic environment and have excellent interpersonal skills, this may be an ideal opportunity for you.
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