Senior Quality Engineer

Overview

We are recruiting a Senior Quality Engineer to join our quality team at a prominent medical device manufacturing company based in Limerick. This full-time position requires onsite presence with working hours Monday through Thursday from 8:00 AM to 4:30 PM, and Friday from 8:00 AM to 3:30 PM.

Key Responsibilities

• Deliver daily quality engineering support for manufacturing lines and production operations.
• Lead and assist Corrective and Preventive Action (CAPA) activities including conducting investigations, root cause analysis, and executing corrective measures.
• Maintain experience in risk management documentation, PFMEAs, test method validations, TMVs, product release testing, regulatory documentation, product transfer activities, and project management.
• Manage Non-Conformance Reports (NCRs) by investigating and ensuring their resolution aligns with quality standards.
• Support validation processes such as process validation, equipment validation, and thorough documentation reviews.
• Utilize engineering methods like Six Sigma and Lean to identify optimization opportunities in manufacturing and R&D processes, including redesigning equipment, tools, and fixtures to enhance manufacturing efficiency and reduce risks.
• Working knowledge of MS Office and CAD software is beneficial.
• Collaborate closely with Manufacturing, Engineering, and Operations teams to address and resolve quality-related challenges.
• Ensure compliance with regulatory standards including FDA, ISO 13485, GMP, and internal quality system protocols.
• Drive continuous improvement projects to enhance quality across the organization.
• Participate in both internal and external quality audits as required.
• Review, approve, and manage quality documentation, procedures, and reports effectively.
• Mentor and provide guidance to junior team members when necessary.

Qualifications and Experience

• A degree in Engineering, Science, Quality, or related fields is required.
• At least 5 years of experience in a Quality Engineering role within the medical device or regulated manufacturing sector.
• Proficient in risk management documentation, PFMEAs, test method validations, TMVs, product release testing, and regulatory documentation management.
• Demonstrated expertise in CAPA handling, NCR investigations, and validation activities.
• In-depth knowledge of FDA, ISO 13485, GMP, and relevant quality management systems.
• Strong analytical skills with proven ability in problem-solving and root cause analysis.
• Excellent communication abilities and experience managing stakeholders at various levels.
• Capability to work independently and prioritize multiple tasks in a dynamic environment.
• Familiarity with high-volume medical device manufacturing settings.
• Understanding of statistical analysis and quality improvement tools; audit experience is an added advantage.

Additional Information

For further details regarding this job opportunity, please contact Gary Keane at phone number 086-1030418 or via email at garykeane@cregg.ie.