Senior QA Engineer - Contract

Bd Medical

Enniscorthy, Wexford

This is an exciting opportunity to join our team during the acquisition of a new product. This role is on a 1 year FTC with the possibility of extension. The successful person will need to be available for regular travel to the USA to visit our suppliers. you will be responsible to assure that all Suppliers, Components and associated activities are appropriately qualified in accordance with local, Corporate and Divisional requirements. Performs supplier audits and on-going supplier surveillance as required. Incorporates risk management, performance and validation inputs as well as applicable Standards and Procedures in planning and implementation of supplier activities. Represents quality interests and concerns on project teams. Summary of Position with General Responsibilities: Assures that all Suppliers, Components and associated activities are appropriately qualified in accordance with local, Corporate and Divisional requirements. Performs supplier audits and on-going supplier surveillance as required. Incorporates risk management, performance and validation inputs as well as applicable Standards and Procedures in planning and implementation of supplier activities. Represents quality interests and concerns on project teams. Essential Job Functions: Leads the Quality engineering activities for Supplier and Component Qualification and related activities. Develops and maintains supplier quality files. Performs supplier audits in accordance with the Audit Schedule. Develops supplier qualification plans, protocols and reports as required. Establishes alignment with risk management documentation. Maintains Approved Supplier List. Performs TMV as applicable. Supporting Activities May include the following: Develops design and process risk management documentation with cross-functional support. Reviews design control compliance requirements for NPD projects. Reviews and approves all design file output from the NPD projects. Support the development of device Design Inputs, Design Outputs, Product Specifications, Product Development Plans, and applicable design control documents. Lead the development of the DFMEA, coordinating input from the other Design Sub-team members. Support (or lead) development of the PFMEA. Executes product sterilisation validation/re-validation and sterile adoption requirements. Develop or assist in development of inspection and test methods per product specifications. Perform test method validations and component qualifications as required. Perform DOE’s and other statistical analysis to support product and process optimization or determine causes of process variation. Initiate corrective actions as required. Supports assessment of Biocompatibility testing required as per ISO10993 and company procedures. Develop or assist in development of inspection and test methods per product specifications. Develop or assist in generation of test protocols and Stability Studies in support of expiration dating. Identifies quality systems engineering improvement opportunities and executes through the change management system. Participates in internal audit and supplier audit programmes. Participates on teams responsible for investigating and providing corrective action for production and supplier nonconformances. Development of robust action plans, projects and verification activities for elimination of potential at compliance and CAPA related risks, as required. Alignment of the quality system with changes in global and corporate quality management standards, policies and regulations. Assists in the Company’s complaint and failure investigation process. Education and/or Experience: Lead Auditor qualification and experience. Validation planning and execution. Risk management – d/PFMEA; Risk Analysis, Risk Management File. Gauge R&R and Test Method Validation. 5 years Supplier Quality experience or equivalent. Risk-based and performance approach to drive and prioritise the internal audit schedule across the facility. Working with cross-functional teams to effectively implement NPD projects, corrective actions etc. Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971 and CMDR. Participation in and support of external audit activities. Third level Engineer/Technical/Science qualification. Min 5 years in the medical device or pharmaceutical industry. Knowledge of quality management systems ISO 13485, GMP. Excellent interpersonal skills with the ability to work in a team environment and work under own initiative to targets and deadlines. Problem solving techniques with excellent organisational skills. Dedication to excellence, flexibility and adaptability to change. Attention to detail and adaptability. About Us. BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health. This job originally appeared on RecruitIreland.com.

1982 days ago