Ref No: AM17715
County Wexford, Republic of Ireland
Design Quality Engineer - County Wexford.
We are recruiting an experienced Design Quality Engineer with New Product Development experience. 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.
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.
Working with cross-functional teams to effectively implement NPD projects
Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971 and CMDR.
Interested candidates should be educated to degree level in Engineering/Technical/Science. Have a minimum of 5 years in the medical device or pharmaceutical industry. A knowledge of quality management systems ISO 13485, GMP etc.
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