Design Assurance Lead, Medtech Development
|Contact Name:||Larry O’Leary|
Our client, a Medtech company with strong development and commercial pipeline, now seek an experienced Design Assurance Lead who will work within Design Assurance having responsibility for leading New Product Introduction; Sustaining Engineering for commercialized products; and Post Market Surveillance activities.
This is a new role within Design Assurance function to support new Product stream, with increased scope of compliance and associated changes within EU MDR legislation. There is flexibility for this hire to work remotely.
This hire will provide leadership, oversight and direction to the Sustaining Design Assurance team. You will manage multiple stakeholders and associated projects, ensuring compliance of all commercial products for this therapy area, including product development systems/processes/complaint handling/data analysis and trending/driving product improvements.
The successful candidate will assist in formulating strategy and lead execution on quality deliverables through product development process, recertification, risk management and design control SOPs, ensuring products meets all applicable regulatory requirements.
This role will appeal to a candidate who wishes to further develop their team leading experience within a Global Design Assurance Quality function, working on change management of existing area and developing the NPD / NPI, Sustaining and PMS areas. Opportunity for progression internally within Site, European and Global teams.
The ideal candidate will be an experienced Design Assurance / Quality Assurance Manager, with depth of experience in managing New Products from Development through to Commercialisation, with oversight of Complaint Management and working with associated Quality systems. Additionally this hire will be experienced in an audit facing role, ensuring compliance of quality systems and products. Expertise in: verification / validation techniques, risk management, statistical techniques and / or post-market surveillance activity is preferred.
Requirements for Design Assurance Lead:
Honours Bachelor's Degree in Science, Engineering or equivalent technical discipline. Advanced qualification is preferred.
10+ years' Quality Assurance experience, ideally in Design Assurance, Design Control, DHF Compliance in a leadership role pertaining to NPD / NPIs.
Strong Leadership experience at organisational level
Proven people management experience is required i.e.: setting goals and objectives, conducting performance reviews, etc. and track record of developing high performing team and culture.
Budgetary Management experience
Proven experience with ISO 13485, ISO 14971, Quality System regulations and FDA regulatory guidelines.
Proven experience with Design Controls, Risk Analysis, Risk Management and Continuous Improvements.
Strong Validation experience, particularly with Process Validation regarding NPIs.
Project Management and Stakeholder Management experience highly desirable.
Please phone Larry on +353 1-2302400 / email@example.com
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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