Design Assurance Manager Galway

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Due to ongong expansion and new product development our client are currently recruting for several positions across their team.The Design Assurance Manager will be a key player in the Company's product development and commercialisation strategy.Principal 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 the 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

-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.

-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.

-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.Your experience and qualifications:- 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.Apply today for immediate consideration To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales