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Quality Engineer

  • Location: County Westmeath
  • Job Type:Permanent
  • Sector: Engineering
  • Contact Email: gillian.nicholson@collinsmcnicholas.ie
  • Job Ref: 18254

We have a new opening for a Quality Engineer to join a multinational medical device company based in the Midlands. This position can be Hybrid.

The Quality Engineer is responsible for supporting the quality projects and activities as defined under key responsibilities below. Responsibilities include supporting NPI and ensuring compliance to all relevant quality system regulations and standards.

Responsibilities:

  • Work with manufacturing sites in all quality system areas including CAPA & NC investigation, complaint handling, audits and quality improvement projects.
  • Quality System compliance to ISO13485, Medical Device Directive, MDR 2017/745, 21CFR820 and other quality system regulations and standards as appropriate.
  • Support internal and external audits.
  • Investigating root cause of quality issues and following through with timely and effective corrective actions to prevent re-occurrence for customer and internal issues.
  • Work closely with R&D to support any improvement activities associated with new product introductions.
  • Support the set-up of the Design Assurance laboratory including the preparing and updating of laboratory procedures and associated documentation.
  • Establishing inspection standards, plans, frequencies and test method validations.
  • Support of all Risk Management activities.
  • Support the execution/documentation as it relates to Usability Studies and Engineering Studies to support NPI.
  • Performs and approves Validations.
  • Compliance testing per relevant standards.
  • Review of Product Technical Drawings.
  • Generate protocol and report for product & packaging performance qualification (including shelf-life).
  • Draft required Quality Systems documentation to support DHF creation for NPIs.
  • Perform other duties requested by management.

Requirements:

  • Bachelor Degree in a Technical field.
  • Minimum 2/3 years’ experience in the Medical Device Industry.
  • Strong Project Management skills and experience with leading and participating in several projects concurrently.
  • The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.
  • Ability to accurately scope projects and consider the full impact of decisions and actions taken. Experience with FDA/HPRA/MDSAP audits desirable.
  • Knowledge of International Quality and Regulatory requirements and regulations including but not limited to FDA’s 21 CFR Part 820 (Quality System Regulation), ISO 13485 Quality System requirements, 2017/745 MDR, Canadian Medical Device Regulations, Japanese JPAL requirements. Attention to detail and accuracy – essential.
  • Ability to work well under deadlines and pressure.
  • Problem solving skills for developing creative solutions and meeting objectives are required.
  • Skills that enable coordination and presentation of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel). 
  • Excellent analytical ability.
  • Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience.
  • Good business acumen.

Behaviours / Values

  • Balanced, Dependable and Fair.
  • Committed, leads by example.
  • Self-starter, able to identify what is essential for business success and align resources and time accordingly.
  • Approachable and enthusiastic.
  • Flexible and adaptable.
  • Able to work on own initiative and as a team player.
  • Good organizational skills with cultural awareness and sensitivity.
  • Able to build good, strong and positive working relationships with cross functional teams across International Regions and Functions.

 Attractive Benefits Package include: Bonus, Remote Working, Health Insurance and Company Pension Contribution

For a full job description and confidential discussion on this role please contact: Ranait Coughlan

090-6450665

ranait.coughlan@collinsmcnicholas.ie