Job description

I'm delighted to be working a Senior Quality Engineer role with an excited client of ours based in Limerick. This Medical Device company is an industry leader, utilising high tech, high growth and cutting edge manufacturing technology. I have recently placed two candidates onto this team, and the feedback about the culture and vision of this company has been phenomenal. This is a permanent role, salary is depending on experience. If you are thinking about joining a company where you will be a valued member of a high performing team, which will allow you to grow as the company goes - please apply below or reach out to me directly.

Responsibilities:

• 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 the company  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.
• Responsible to deliver department and organizational level objectives.

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.