Sr. Quality Engineer

Position Summary

Title:                             Senior Quality Engineer, Quality Systems

Reports to:                   Senior Manager, Quality

Department:                Quality    

Purpose of the role:     

Quality leader to drive Global and Internal programs, systems development and improvement activities relating to the operation of the Quality Management System.

Principal Responsibilities

Key responsibilities will include (but are not limited) to the following

• Manage, support and monitor the CAPA process.
• Lead, drive and monitor effectiveness of the Internal audit process
• Manage and host, Customer and regulatory audits.
• Site project leader for the Teleflex Global QMS projects as required.
• Site quality technical lead for software approval / Information System projects as required.
• Preparation of monthly and management review data metrics on Quality System and Quality performance e.g. Complaints, NC’s, CAPA, Audits, supplier performance etc.

Education / Experience Requirements

• Degree in Engineering/ Quality discipline is essential.
• Min 5-10 Years’ experience in Quality Systems Management in the Medical Device /Component Industry.
• Certified QE, desirable
• Technical report writing skill
• Statistical knowledge (DOE, SPC, Sample comparison, etc.)
• Working knowledge of Risk Management and validation principles
• Previous experience of Managing project teams desirable.
• Planning and Organisation skills – Project and programme oversight, sponsorship and management

Specialized Skills / Other Requirements

People

• Performance Management of others
• Coaching and mentoring
• Employee Development
• Excellent Written and Verbal Communications.
• A positive attitude in dealing with people.
• Proven ability to lead and give direction to team members on all aspects of Quality Systems
• Ability to lead meetings
• Ability to work in a cross functional team
• Display High levels of emotional intelligence
• Display Qualities and Principles of Genuine Leadership

Customer and Vendors

• Ability to generate appropriate relationships with customers
• Ability to deal with difficult customer communications