Quality Engineer -Med Device-South East of Ireland
My client a leading medical device company is looking for an experienced Quality Engineer with New Product Development experience, to join their state-of-the-art facility in Wexford
- 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.
- 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
Education and Experience:
- The successful candidate will be educated to degree level in Engineering, Science or Quality related discipline.
- You will have relevant work experience in a regulated medical device or pharmaceutical environment- with exposure to ISO 13485.
- You will have experience in moulding and process validation along with CAPA and non-conformance, problem solving and preventative measures skills.
- You will be a strong and influential communicator with attention to detail and process excellence.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.