I'm currently working with one of our most highly sought after clients in Limerick for a Senior Quality Engineer to join their growing team as they continue to expand their workforce and manufacturing facility in Limerick.  Be part of a company with an innovative R&D hub and technologies, plus a unique thriving team. This company have great ambitions, a drive to scale and state of the art technology. I have heard amazing things about this company from the people we have already placed, and the lovely working relationship we have with the senior leadership team. You won't want to miss this chance to join this company on a permanent basic. Strong salary and benefits package included, all depending on experience. 

YOU’LL GET A CHANCE TO:

• Excel in the technical competence required for the role, include but not limited to:
  • Specification development, CTQ mapping, test method development and validation, process validations and implementation of CCP within the process, using error proofing, process monitoring, SPC.
  • Complaint handling, NC management, Risk and Impact assessment, CAPA, Root cause investigation and solution development and verification and Change control.
  • Supplier Quality Management.
  • Product release.
  • Product test and release planning, change management and audit.
  • Critical thinking and technical writing.
• Quality lead on multi/cross functional teams to achieve milestones and results.
• Represents in Customer interactions relating to product process and system quality elements in a professional, constructive, and commercially aware manner.
• Ensures that customer product requirements are defined and implemented within the site QMS
• Engage with the new product development team to ensure a smooth transition from development to production.
• Identify and implement continuous improvements across the board and takes initiatives to make things better every day.
• Owns and drives the Safety/Quality/Service/Cost Metric for the VS.
• Leads by example and demonstrates to agreed behaviors.
• Aligns the goals and objective setting for the VS in collaboration with management
• Executes on Lean initiatives bringing everyone else on board.
• Is committed to develop, coach, motivate self and team Leads the VS based on influencing skills without having the hierarchy of all team members.
• Builds relationships with key stakeholders in the company and addresses their needs of communication and information.
• Ensure full compliance with regulatory requirements.
• Ensure Quality and EHS policies and procedures are adhered to at all times.
• Subject matter expert across the Quality Management System.

Required:

• Minimum Level 8 Qualification.
• Minimum of 5 years of direct QMS experience
• On the job training will be provided for the right candidate.
• Strong written and oral communication skills.
• Experience working with medical device regulations is desirable.
• Good computer skills in usage of MS Office Suite

• Working knowledge of EN ISO 13485, FDA QSR 21 CFR Part 820 and principles of GMP in the Medical Device Industry.

For more information, please apply now or email julieannfitzpatrick@sigmar.ie for a private and confidential chat.