Job Description
Our client, a Medtech company with strong development and commercial pipeline, now seek an experienced Senior Design Assurance Manager who will work within a global Design Assurance function having responsibility for leading commercial product performance, sustaining engineering and post marketing surveillance activities for a high-value, high-growth therapy area which is supported by significant corporate investment.
Flexibility for this hire to work in a hybrid work model, on site in Galway some days as required and from home remainder of time.
The successful candidate will provide leadership, oversight and direction to the Sustaining Design Assurance team for this therapy area globally. You will formulate strategy and lead execution on quality deliverables through product development process, recertification, risk management and design control SOPs, ensuring all therapy area products meets all applicable regulatory requirements.
This hire will manage multiple global 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.
This role will appeal to a candidate who wishes to further develop their leadership experience within a Global Design Assurance Quality function, working on change management of existing therapy area and developing the 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.
Technical expertise in: design assurance, verification / validation techniques, risk management, sustaining, complaint management and / or post-market surveillance activity is preferred.
Requirements for Senior Design Assurance Manager, Global role:
Honours Bachelor's Degree in Science, Engineering or equivalent technical discipline. Advanced qualification is preferred.
8+ years' Quality Assurance leadership experience, ideally in Design Assurance, Design Control, DHF Compliance or Quality role pertaining to NPD / NPIs in Medtech industry.
People management experience is preferred i.e.: setting goals and objectives, conducting performance reviews, etc.
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 contact Larry on +353 1 2302400 / larry@rftgroup.ie
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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