Medical Devices JobsQuality Engineer

  • CJ50086
  • Permanent
  • Clare, Limerick

Collins McNicholas

Responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. Transfer the manufacturing process of product from sister site. This includes the creation / development of procedures, manufacturing workflows, validation of required processes, developing inspection control plans, analysing quality trend data and taking appropriate action; supporting production on all quality related issues; investigating customer complaints; and ensuring an effective and robust quality system which complies with all relevant regulatory requirements.

 

Principal Duties & Responsibilities

  • Formulates procedures, specifications, and standards for Zimmer products and processes.
  • Provides leadership for quality engineering projects from concept through design, implementation, testing, documentation, support, and maintenance.
  • Develops and implements corrective/preventative action plans.
  • Collects and analyzes data for gauge and product evaluation.
  • Develop and maintain an effective and robust quality system which complies with all relevant regulatory requirements.
  • Ensure all validation activity is effective and documented in a compliant manner.
  • Complete in-depth investigations into, product non-conformances, customer complaints and implement corrective and preventative actions, as appropriate.
  • Identifies critical personnel, gauges, procedures, and materials needed for the completion of new products.
  • Ensures that suppliers have necessary information and facilities to deliver quality products to Zimmer.
  • Certifies product builders to ensure they have the required skills to complete their operation.

 This is not an exhaustive list of duties or functions and may not necessarily comprise all of the “essential functions” for purposes of the ADA

 

 Essential  Requirements

  • Third Level Degree in Quality or Engineering field
  • 1 year service in ZOML (at start date)
  • 2 years relevant experience in a relevant quality technician role
  • Excellent communication and influencing skills
  • Microsoft Office Suite.
  • Understanding of QSR/ISO regulations
  • Risk assessment skills using FMEA methodology
  • Product testing methods, and able to use hard gaging and optical comparators
  • Knowledge of statistics, process control, and process capability
  • Demonstrated NCR / CAPA experience
  • Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.)
  • Facilitates team efforts on quality engineering projects.
  • Ability to deliver, meet deadlines and have results orientation
  • Able to communicate both orally and in written form to multiple levels of the comp

Desired

  • Demonstrated history of taking initiative, meeting commitments and assisting in the creation of new tools or solutions to achieve business results
  • New Product Introduction / Product transfer experience
  • Process / software validation Experience

For a confidential discussion contact deirdre.sheehan@collinsmcnicholas.ie or on 061512270

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