Design Assurance Manager

Design Assurance Manager


Our client a Galway based Medical Device company is currently seeking a Design Assurance Manager to join their team. Reporting to Quality Director the Design Assurance Manager will be a key player in the Company’s product development and commercialisation strategy.


Role/Responsibilities

• Work within the quality system and ensure that the quality policy and company systems and procedures are complied with in line with the Medical Device Directive 93/42/EEC, Medical Device Directive 2007/47/EC, FDA Quality System Regulations 21 CFR Part 820, FDA GLP Regulation 21 CFR 58, ISO 13485, ISO 14971, Japanese Ministerial Ordinance #169.
• Lead the development / evolution of Design Control, Risk Management and associated systems, to encompass new product development technologies.
• Identify DA resource needs. Put in place and develop DA resources, as required.
• Provide Design Assurance input to R&D project teams for designated projects o Define design assurance requirements for projects and design changes, including resourcing and timeline planning.
• Understanding the Regulatory requirements for device developments and providing input to projects to encompass these requirements.
• Participate in specification development in relation to design input development. Lead the generation of Design input / Output documents.
• Lead the risk management activities for designated projects and design changes.
• Design, development and validation of test methods as required to support development programs.
• Develop and maintain design verification and validation plans, protocols and reports.
• Support R&D in the preparation and delivery of Design Reviews and associated checklists. o Manage the conduct of non-clinical studies at third party facilities in conjunction with R&D department.
• Establish and maintain the Design History File and associated documents. o Provide QA support to R&D for equipment management.
• Manage assigned aspects of the project, as required.
• To be the QA Manager designate as the Person Responsible for Regulatory Compliance (PRRC) as required by MDR 2017/745 for the activities outlined in QS085.

• A degree level qualification in Engineering, Science, QA or related field is required. Experience
• A minimum of seven years’ relevant experience in the medical device or pharmaceutical industry, preferably with Stent and Stent Coating technology experience.
• An understanding of ISO13485, ISO14971 and FDA QSRs is a prerequisite.
• Familiarity with statistics, validation and physical testing is required.
• Good communication and organisational skills, and the ability to present reports nearly and accurately is essential