Design Assurance Lead, SME
|Contact Name:||Larry O’Leary|
Our client, a Medtech company with strong development pipeline, now seek a Design Assurance Subject Matter Expert who will have Quality responsibility for new products transitioning from product development through to commercialisation. Flexibility for remote working within Ireland.
This hire will provide leadership, oversight and direction to the Design Assurance team, while managing multiple stakeholders and associated project teams, ensuring compliance of all new products transitioning from R&D through product development systems/processes in an FDA regulated manufacturing environment.
The successful 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.
Additionally this hire will direct Design Assurance team resources to lead all program/projects through verification / validation techniques, risk management, statistical techniques and associated regulatory requirements.
The ideal candidate will be a Design Assurance professional who is a subject matter expert and experienced in QA activities involving New Product Development / New Product Introduction activities, including; defining processes and procedures in line with Quality Systems, product verifications, validations and risk management, leading pre-audit campaigns, etc.
Requirements for Design Assurance Lead:
Honours Bachelor's Degree in Science, Engineering or equivalent technical discipline. Advanced qualification is preferred.
8+ years' Quality Assurance experience, ideally in Design Assurance, Design Control, DHF Compliance in a leadership role pertaining to NPD and NPIs.
People management experience is required 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.
Proven Project Management and Stakeholder Management experience.
Please contact Larry on +353 1 2302400 / firstname.lastname@example.org
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
Follow us on: Facebook, Linked-in, twitter