Quality Engineering Lead - Medical Device Team Leader

Sanmina Corporation; Fermoy; On-site; EUR 65,000 - 90,000; Full time

Job summary

Sanmina Corporation in Fermoy, Ireland seeks a Quality Engineering Lead to manage a team of quality engineers, ensure regulatory compliance and maintain quality metrics across manufacturing lines. The role includes development of in-house procedures, mentorship of engineers and support for audits and customer reporting.

The ideal candidate has 2–3 years in a high-volume engineering setting with automation knowledge, strong regulatory experience (FDA QSR, ISO 9001/13485, MDD) and proficiency in

Qualifications

• 3rd Level Quality / Engineering or Technical Degree qualification Level 8 min.
• 2/3 years experience in a high-volume engineering environment with automation principles.
• Working knowledge of FDA QSR, ISO 9001, ISO 13485, and Medical Device Directive.
• Proficient in Excel, Word, PowerPoint.

Responsibilities

• Manage Quality Engineering function including Quality Plans, FMEA’s, control plans, SOPs and Event Investigations.
• Create, analyses, report and improve Product & Line Controls and ensure Quality Metrics are used to drive data decision making on a day to day basis.
• Review, approve and drive continuous improvement in event investigation forms and techniques.
• Driving required Corrective and Preventative action Improvements as output of Event Investigation process.
• Creation and Maintenance of departmental processes and procedures.
• Support External Agency Audits.
• Quality Tools & use of Best practice techniques and ideas.
• Quality Reporting/Metric gathering where required.
• Quality Improvement by account line and area.
• Other duties as required by the Head of Quality.
• Quality:
• Assure ongoing compliance with quality and industry regulatory requirements.
• Health & Safety:
• Ensure compliance with Health & Safety Legislation and Regulations.

Skills

Quality management

Regulatory knowledge

Problem solving

Team leadership

Education

Quality/Engineering degree (Level 8)

Tools

Excel

PowerPoint

Job description

Sanmina Corporation in Fermoy, Ireland seeks a Quality Engineering Lead to manage a team of quality engineers, ensure regulatory compliance and maintain quality metrics across manufacturing lines. The role includes development of in-house procedures, mentorship of engineers and support for audits and customer reporting.

The ideal candidate has 2–3 years in a high-volume engineering setting with automation knowledge, strong regulatory experience (FDA QSR, ISO 9001/13485, MDD) and proficiency in