Quality Engineering Lead

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

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Category (For Job Seekers)

Quality

Location

34501 - EMS FERMOY IRE - Fermoy, CO IE (Primary)

Job Description

JOB TITLE: Quality Engineering Lead

DEPARTMENT: Quality Department

REPORTING TO: Head of Quality

Individual Contributor or People Manager: People Manager

OBJECTIVES OF POSITION:

• Manage a team of Quality Engineers responsible for operational quality activities.
• Manage Operational support to maintain effective support as required.
• Develop in house procedures, Work Instructions, best practice for problem solving and line investigations etc.
• As a senior member of the Quality department you will also be the mentor for Quality Engineers and Lead Quality Technicians ensuring information and Quality approach is best in class.
• Support the management of the Event Investigation forum and required best practice problem solving techniques including weekly Yield data gathering and monitoring on selected accounts as required.
• Support Weekly Customer reports as well as Quarterly Business Reports and data presentation when required.
• Training management of Quality Engineers ensuring all team members are focused on achieving company goals and targets.

RESPONSIBILITIES:

• Manage Quality Engineering function including Quality Plans, FMEA’s, control plans, SOP's 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.

MEASUREMENTS:

• Performance improvements in the above areas to current baseline.
• Improved customer satisfaction in delivered quality.
• EIF open / closed timeliness.
• Development, and training of Quality Engineering personnel.
• Completion of tasks / projects against set objectives in performance review.

PERSONNEL SPECIFICATIONS

• Qualifications and Experience:
  • 3 rd Level Quality / Engineering or Technical Degree qualification Level 8 min.
• 2/3 Years experience in a high volume engineering environment with excellent understanding of Automation principles and associated Technical requirements.
• Ability to create a team environment conducive to problem solving.
• Working knowledge of current FDA Quality Systems Regulation, ISO 9001, ISO 13485, and the Medical Device Directive required.
• Proficient in use of Excel, Word, Power-point applications.
• Ability to read, analyse, and interpret quality metrics is preferred
• Ability to respond to common inquiries or complaints from internal customers and regulatory agencies is preferred.
• Ability to write standard operating procedures and training documents is preferred.
• Ability to effectively present information to customer and internal personnel at all level.
• Core Competencies:
  • Excellent communication and influencing skills are essential.
  • Good understanding of Quality and Regulatory requirements related to the medical device industry.

Good analysis and problem solving skills