Design Quality engineer II

Recruiter
HERO Recruitment
Employment Type
Permanent
Salary
Not disclosed
HERO Recruitment logo

Design Quality Engineer II

We know it’s not all about the money when you’re looking for your next Design Quality Engineering job but we also know it’s important too! HERO are working with a global leader in Medical device to find the very best of talent for their Wexford operation. Why should you apply? This Design Quality Engineering job opportunity in Wexford offers exceptional career development opportunities whilst delivering excellent salary and benefits package. Let’s talk to see if this is the right move for you.

Purpose
We are looking for an experienced Design Quality Engineer with New Product Development experience for our state of the art facility in Enniscorthy. 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.

Responsibilities

  • 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.

Key Requirements

  • 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.

For further information on this role in Wexford please contact Aisling Kidney on or

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Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.