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Quality and Inspection Engineer – Medical Devices


  • DOE
  • North County Dublin
  • Permanent

Our client, a leading medical device manufacturer in North County Dublin has instructed us to hire a Quality and Inspection Engineer to deal exclusively with suppliers / incoming goods. The Supplier Quality & Purchased Material Inspection (PMI) team works cross functionally with engineering, production, and procurement with responsibilities focused on maintaining a high level of delivered quality from suppliers. This includes on boarding new suppliers, incoming material inspections, supporting suppliers to deliver quality parts, supplier quality rating, material quality purges and related technology transfers activities including new supplier introduction. Call Cormac Spencer on 01 845 4651 for more details.

Ensuring the maintenance of QMS and Regulatory compliance is a key requirement. This role is responsible for a key support activity onsite supporting our supplier quality management services within an ISO 13485 and FDA 21 CFR Part 820 regulatory environment.

The role reports to the Supplier Quality & Incoming Inspection Manager.

Salary: DOE

Benefits: Flexible working, Healthcare, Pension, Bonus, Sports and Social, Subsidised Canteen

Duties:

  • Develop world-class supply chain processes to suit a low volume, high complexity multi-technology environment (diagnostic instrumentation).
  • Manage suppliers to deliver quality product to internal customers, through product & process investigations & evaluations.
  • Liaising with a wide variety of external suppliers to ensure suppliers are trained and adhere to Siemens First Article, Quality and Regulatory requirements.
  • Develop strong value-added ties with the customer base.
  • Issuing of Supplier Corrective Action Reports and working with suppliers on Root Cause Investigations and Corrective action.
  • Conducting Supplier Performance Reviews and Reporting of Key Supplier Quality metrics.
  • Performing an active role within project core teams to ensure further development and continuous improvement of Supplier Management and Incoming Inspection Processes
  • To support technology transfer initiatives and new projects. Involving the assessment and selection of new suppliers where applicable.
  • To develop and implement appropriate parts (components, subassemblies, modules) inspection plans to maintain a high delivered parts quality.
  • To provide day to day inspection expertise in the areas of Component and Mechatronic Inspection supporting manufacturing and acting as a technical reference to interface with the supplier.
  • To contribute to the continuous development of the quality system, including standard operating procedures (SOP’s), product and process validations coupled with the ability to write concise technical reports.
  • Achieving and sustaining a focus & commitment to Quality with suppliers.  Support a Strong Supplier focus to ensure that that requirements are met appropriately and oversee relevant KPIs for supplier quality oversight.
  • The Supplier Quality team serves a variety of both internal and external customers primarily engaged in the provision of parts to manufacture instrumentation in the Medical Diagnostics area for supply worldwide.
  • Internally supporting the demands of the instrument and spares supply manufacturing operation.
  • Working with external functional quality and supplier management groups within the business

Competencies

  • Mechanical, Mechatronic and Electromechanical measurement systems – Advanced
  • Inspection Methodologies such as; PCBA Visual Inspection (IPC-A-610), Fabricated/Machined Metal Mechanical / Visual inspection, Precision linear measurement, non-contact measurement, Moulded and Machined plastics inspection and measurement.  Inspection and Measurement of Lens and focal length.  – Advanced
  • General Inspection to Drawing; Commercial off the shelf components, inspect against vendors item or model number – Advanced
  • Geometrical Tolerancing (e.g. true position, perpendicularity, concentricity,  angularity, roundness etc.) – Advanced
  • Process and Supplier Auditing capability and experience – Advanced
  • Ideally have a working knowledge of Six Sigma, Statistical Analysis and Lean principles for investigations, problem solving and continuous improvement

Qualifications/Required Experience

  • 3 years + relevant experience within a similar environment.
  • Minimum of a third level qualification (Diploma/Degree) in an appropriate discipline (Quality Management, Mechatronics, Electronics or Mechanical Engineering) OR appropriate and commensurate experience.
  • Experience in leading and being a part of teams and projects with strong communications written and verbal. Ability to work in technically complex multi discipline areas across the whole supply chain, including the supplier environment

If this Quality and Inspection Engineer role sounds like YOU, call US.

Speak to the Experts with the Direct Link to the Best Medical Device Jobs in Ireland

Link Personnel

www.linkpersonnel.ie

01 845 4651


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