Quality Engineering Leader

3 days ago

Limerick, Limerick, Ireland beBeeQuality Full time €90,000 - €120,000
Job Overview

A high-impact Quality Engineering Team Lead role is now available, offering a unique opportunity to lead and supervise a talented team of Quality Engineers. The successful candidate will be responsible for setting objectives, creating training plans, coaching team members, conducting performance appraisals, and addressing performance-related issues.

Key Responsibilities
  • Drive all assigned Quality Engineering projects, ensuring they are managed in a structured fashion and completed in compliance with relevant procedures.
  • Manage project activities to ensure timely completion of milestones.
  • Represent the team at key review meetings.
  • Build effective relationships with Operations, IT, Engineering, and Regulatory teams.
  • Lead FDA, QSR, and ISO 13485 requirements, promoting best industry practices and making decisions using quality engineering principles.
  • Identify and implement opportunities for improvement.
  • Maintain a proactive approach to developing and implementing quality systems to meet changing business needs.
  • Ensure timely resolution of in-house or external quality issues.
  • Responsible for quality systems, including design, process, and software validation, supplier quality, CAPA, non-conformances, and internal audit programs.
  • Support trend analysis of key quality metrics and risk assessment throughout quality engineering key processes and systems.
Requirements
  • Third-level qualification in Science, Engineering, or a relevant technical discipline.
  • Proven knowledge and experience (ideally 6 years) of working with ISO 13485, ISO 14971, the Medical Device Directive, EU Medical Device Regulation 2017/745, and FDA QSR, including 21 CFR Part 820 and 21 CFR Part 11, preferably gained in the medical device industry.
  • Previous supervisory experience is beneficial.
  • Excellent communication and interpersonal skills.
  • Proven track record of pursuing continuous self-improvement.
  • Good working knowledge of Microsoft Office.
  • Proven problem-solving skills.
  • Good working knowledge of statistics.
  • Knowledge and experience of all aspects of validation.
  • Excellent organisational, time management, and presentation skills.
  • Excellent attention to detail.
  • Proven self-starter.
  • Willingness to travel on company business.

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