Assoc Dir QA Med Device

CAREERWISE RECRUITMENT

LIMERICK

An Assoc Dir QA Med Device is required for our Limerick based trailblazing pharma client. This role provides QA oversight of the Medical Device/Combination Products including pre-filled syringe and auto-injectors/pen injectors for biological therapeutics developed in-house and in collaboration with partners and CMO's. THE ROLE: * Provide leadership to the Medical Device Quality Oversight team. Implement and maintain the Quality Management System ensuring compliance to all applicable combination product/medical device regulations. * Provide Quality Assurance oversight for the Combination Product Development function. * Provide guidance and participate in Design Development, Design Transfer, and Commercialization reviews and activities; and where appropriate in Feasibility, Development, Design Verification, Design Validation activities associated with combination products. * Function as the primary interface for QA advising on combination products quality issues within the organization. Work effectively and influence multiple functions (Combination Product Development, Operations, Commercial, Regulatory, Supply Chain, etc.) to ensure quality requirements are met. REQUIREMENTS: * The preferred candidate will have 5 years of relevant experience with a Bachelor's degree (Life science / Engineering. * Proven experience in global applications of Quality Risk Management and Quality Assurance in the medical device field at a multi-site level. * Device regulation (design control) experience required. Please call Michael Hanrahan today for further information on 021-2019817 or email: mhanrahan@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

1618 days ago