Medical Devices jobs in Munster

Takumi Precision Engineering supplies components to aerospace and medical customers. We're looking for a Quality Engineer to maintain and improve our quality systems - leading audits, managing compliance, and running equipment/process validation so every product meets regulatory and customer requirements.

Responsibilities:

• Plan and lead internal audits against ISO 9001, AS9100, ISO13485 and customer standards.
• Conduct and support external and supplier audits, as needed.
• Issue and manage non-conformances (NCRs/SCARs/ 8Ds), driving root-cause investigation and corrective/preventive action to closure.
• Support Account Managers with Returned Product processing and responses.
• Maintain REACH, RoHS, WEEE and chemical compliance - SVHC tracking, SDS management, and supplier material declarations.
• Own equipment and process validation (IQ/OQ/PQ) - author protocols, execute testing, and manage re-validation. Design and run Gauge R&R studies, MSA, and process capability analysis (Cp/Cpk/Ppk), etc.
• Support APQP activities including DFMEA/PFMEA, Control Plans, and PPAP submissions.
• Track quality KPIs (scrap, PPM, first-pass yield, COPQ) and report trends to the Quality Manager and leadership.
• Maintain quality procedures, work instructions, and document control; support management review.
• Support continuous improvement - Kaizen, Six Sigma (DMAIC), and Lean - and train teams on quality standards/procedures.

Your skills and experience should include:

• Level 7 degree (or equivalent) in Engineering, Manufacturing, Materials Science, or related discipline.
• Experience in quality engineering within precision, aerospace, medical, or automotive manufacturing.
• Hands-on experience with internal/supplier audits and IQ/OQ/PQ validation protocols in Medical Device and/or Aerospace sector.
• Practical experience designing and analysing Gauge R&R studies, MSA, and capability analysis tools (e.g. Minitab); experience with APQP, FMEA, and PPAP.
• working knowledge of REACH and RoHS and other environmental regulation compliance and reporting.

The Ideal Candidate:

Analytical and detail-oriented, with the communication skills to work confidently from shop floor to senior leadership. Organised enough to juggle multiple priorities, collaborative across engineering, production, and supply chain, and proactive about spotting risks before they become problems.

Benefits:

• On-site parking

Ability to commute/relocate:

• Limerick, County Limerick: reliably commute or plan to relocate before starting work (preferred)

Work authorisation:

• Ireland (preferred)

Work Location: In person