Quality/Process/NPD Engineer

Gemma Hayes Recruitment1

Wexford

We are looking for an experienced Quality/Process/NPD Engineer with New Product Development experience for our state-of-the-art facility in Wexford. The Design Quality Engineer assures that new product designs and the processes for manufacturing them meet all local, Corporate and Divisional requirements with respect to safety and efficacy. • Represents quality interests and concerns on project teams. • Leads risk management activities and leads the Quality engineering activities for NPD projects. • Must be able to handle multiple projects and tasks, from product inception through product launch and maintenance. • Reviews design control compliance requirements for NPD projects and all design elements. Reviews all associated documentation. • Leads the development of the DFMEA, coordinating input from the other design sub-team members and supports the development of the PFMEA. • Performs 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. • Participates in internal audit and supplier audit programmes. • Development of robust action plans, projects and verification activities for elimination of potential at compliance and CAPA related risks, as required. • Risk management – D/PFMEA; Risk Analysis, Risk Management File and Gauge R&R and Test Method Validation. Root cause analysis. • Working with cross-functional teams to effectively implement NPD projects, to include Quality, R&D, Supply Chain, Regulatory and Manufacturing departments. • Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971 and CMDR. Successful candidates must be educated to degree level Engineering/Technical/Science. Have a minimum of 5 years in the medical device or pharmaceutical industry. They require a knowledge of quality management systems ISO 13485, GMP etc. They also require excellent interpersonal skills with the ability to work in a team environment and work under own initiative to targets and deadlines coupled together with problem solving techniques with excellent organizational skills. Dedication to excellence, flexibility and adaptability to change are also a plus.

1497 days ago