A respected medical device client are looking for an experienced Quality Engineer with New Product Development experience to join their team in Wexford.
• 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.
• Must be able to handle multiple projects and tasks, from product inception through product launch and maintenance.
• Leads the Quality engineering activities for NPD projects
• 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
• Supports the development of device Design Inputs, Design Outputs, Product Specifications, and applicable design control documents.
• Leads the development of the DFMEA, coordinating input from the other Design Sub-team members.
• Supports (or lead) development of the PFMEA.
• Develops or assists in development of inspection and test methods per product specifications.
• Performs test method validations and component qualifications as required
• Performs DOE’s and other statistical analysis to support product and process optimization or determine causes of process variation. Initiate corrective actions as required.
• Reviews and challenge statistical rationale, plan and data analysis in the frame of test protocol / reports.
• Supports assessment of Biocompatibility testing required as per ISO10993 and company procedures.
• Assists 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
• 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.
• Validation planning and execution
• Risk management – D/PFMEA; Risk Analysis, Risk Management File
• 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
• Participation in and support of external audit activities.
• Auditor experience
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.
If you would like further Information you can contact the recruiter directly:
Claire Kenny | Tel: +353 (0) 1 507 9287