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:

+ 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.


• 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

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