Principal Recruitment Consultant
Senior Quality Engineer – Medical Device Manufacturing
Job Type: Full-time onsite – Parkmore, Galway
Reports To: Quality Manager
About the Role:
Our client, a highly respected and innovative medical device manufacturer, is seeking a Senior Quality Engineer to join their team. This is an exciting opportunity for a hands-on professional who thrives in a regulated manufacturing environment, with a strong focus on ISO 13485 compliance, continuous improvement, and leadership.
Key Responsibilities:
1. Lead and manage a team of quality professionals, providing mentorship and fostering a culture of excellence and accountability.
2. Ensure compliance with ISO 13485, FDA regulations, and other applicable standards in all quality assurance activities.
3. Develop, implement, and maintain quality systems, processes, and procedures to ensure regulatory compliance and product quality.
4. Drive root cause analysis and corrective/preventive actions (CAPA) to resolve quality issues and enhance manufacturing processes.
5. Lead internal and external audits, including customer and regulatory body inspections.
6. Collaborate cross-functionally with engineering, production, and regulatory teams to optimize product quality and process efficiency.
7. Oversee risk management activities, including FMEA (Failure Modes and Effects Analysis) and process validation.
8. Implement and manage statistical process controls (SPC) and data-driven quality improvement initiatives.
9. Drive continuous improvement projects using Lean and Six Sigma methodologies.
10. Provide training and guidance on quality standards, regulatory requirements, and best practices.
Required Qualifications & Experience:
1. Bachelor’s degree in Engineering, Quality Management, or a related field.
2. Minimum of 5+ years of experience in a medical device manufacturing environment.
3. At least 3 years of people management experience in a quality function.
4. Strong knowledge and hands-on experience with ISO 13485, FDA regulations, and QMS requirements.
5. Proven ability to lead investigations, perform root cause analysis, and implement effective CAPAs.
6. Experience with validation protocols (IQ, OQ, PQ), risk management, and statistical analysis.
7. Excellent problem-solving, decision-making, and analytical skills.
8. Strong leadership, communication, and interpersonal skills.
9. Experience with quality tools such as 8D, Six Sigma, Lean Manufacturing, and SPC is highly desirable.
Why Join Our Client?
1. Opportunity to work in a cutting-edge medical device manufacturing environment.
2. Competitive salary and benefits package.
3. Career growth opportunities in a highly regulated and innovative industry.
4. Be part of a strong team, well supported technically by an established team and a Quality Manager who will provide strong support from onboarding.
5. Flexibility is offered with this position with 1 day a week working from home.
If you are a proactive and hands-on Senior Quality Engineer looking to take the next step in your career, we encourage you to apply today!
Contact Lisa Lawlor at stem@hero.ie or call 0868395533 for more information.
#J-18808-Ljbffr