Design Assurance Lead
|Contact Name:||Larry O’Leary|
Our client, a blue-chip healthcare company based in Galway, now seek a Design Assurance Lead for New Product Development (NPD). 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.
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 experienced in QA activities involving New Product Development / New Product Introduction activities, including; product verifications, validations and risk management in an FDA regulated manufacturing environment.
Requirements for Design Assurance Lead:
Honours Bachelor's Degree in Science, Engineering or equivalent technical discipline.
8+ years' Quality Assurance experience, ideally in Design Assurance, Regulatory Compliance or a QA role involving New Product Development and New Product Introductions.
Ideally people management and project management experience.
Proven experience with Risk Management and Continuous Improvements.
Strong Validation experience, particularly with Process Validation regarding NPIs.
Proven Quality Systems knowledge and experience to FDA regulatory guidelines.
Please contact 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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