Quality Engineering Lead

Sanmina; Fermoy; On-site; EUR 90,000 - 120,000; Full time

Job summary

Sanmina Fermoy in Ireland seeks a Quality Engineering Lead to manage a team of Quality Engineers and ensure adherence to FDA QSR, ISO 13485 and related medical device requirements.

You will develop in-house procedures, lead investigations, and deliver weekly reports, while mentoring staff and maintaining quality metrics.

This role partners with Head of Quality to drive continuous improvement and compliance across programs in a fast-paced manufacturing environment.

Qualifications

• 3rd 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.
• 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

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.
• Assure ongoing compliance with quality and industry regulatory requirements.
• Ensure compliance with Health & Safety Legislation and Regulations.

Skills

Regulatory knowledge

Leadership

Problem solving

Communication

Automation principles understanding

Education

Quality/Engineering degree (Level 8)

Tools

Excel

Word

PowerPoint

Job description

JOB TITLE: Quality Engineering Lead

DEPARTMENT: Quality Department

REPORTING TO: Head of Quality

Individual Contributor or People Manager: People Manager

About Sanmina Fermoy

Our Fermoy, Ireland, facility is FDA registered and certified to ISO ISO13485:2016 for the manufacture of high-quality PCBAs, subassemblies and complete devices up to and including Class III medical devices. Sanmina Fermoy’s core specialization is manufacturing automation. We provide services for the entire product lifecycle from New Product Introduction (NPI), prototyping and process validation to complex volume manufacturing & test, shipping and repair. We create a state-of-the-art environment for manufacturing medical and other high-quality devices. The facility has a track record of 30 years of outstanding operational performance and customer service, backed by a highly experienced workforce. We hire people with a range of skills, experience, and backgrounds to fulfill roles in careers such as engineering, quality and manufacturing to name just a few.

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.
• Assure ongoing compliance with quality and industry regulatory requirements.
• 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

• 3rd 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.
• 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