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Telephone: 022 46969

Mobile: 087 9669394

E-mail: rachel@rtlanerecruitment.ie, tom@rtlanerecruitment.ie

Senior Quality Engineer

Senior Quality Engineer urgently required for leading Medical Devices company in Wexford.

Fabulous career progression, excellent work life balance, and flexitime available with this Multi national. 

Responsibility for: 
 

  • Leads the Quality engineering activities for NPD projects, supporting and participating in NPD teams
  • 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
  • Support the development of device Design Inputs, Design Outputs, Product Specifications, Product Development Plans, and applicable design control documents.
  • Lead the development of the DFMEA, coordinating input from the other Design Sub-team members.
  • Support (or lead) development of the PFMEA.
  • Executes product sterilisation validation/re-validation and sterile adoption requirements
  • Develop or assist in development of inspection and test methods per product specifications.
  • Perform test method validations and component qualifications as required
  • Perform 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.
  • Develop or assist in development of inspection and test methods per product specifications.
  • Develop or assist 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
  • Participates on teams responsible for investigating and providing corrective action for production and supplier nonconformances.
  • 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, policiesand regulations.
  • Assists in the Company’s complaint and failure investigation process.

Skills: 
 

  • Third level Engineer/Technical/Science qualification
  • Min 5 years in the medical device or pharmaceutical industry
  • Knowledge of quality management systems ISO 13485, GMP
  • Excellent interpersonal skills with the ability to work in a team environment and work under own initiative to targets and deadlines
  • Problem solving techniques with excellent organisational skills
  • Dedication to excellence, flexibility and adaptability to change.
  • Attention to detail and adaptability

Please call RT Lane for more details on this Permanent role 022 46969 or email rachel@rtlanerecruitment.ie