Quality Technician

Job Description
Title: Quality Technician (Development Value Stream)

Reports to: Quality Engineer

Department: Quality

Purpose of the role: This role is to provide QA support and decision making to the Development Value Stream, through the entire product development process up to and including transfer to production.

Key Responsibilities:

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

•Shift Quality Technician providing front line manufacturing support for multiple development projects. Ensure effective and efficient handover to rotating shift team members as required.
•Generate and ensure adherence to quality inspection plans and conduct final review of batch documentation, including release of product on the MIS system.
•Generate and review of temporary deviations, process, and rework instructions.
•Coordinate, support and/or perform the inspection of development product including but not limited to FAI, checklist builds, builds under deviation/Instruction and protocol requirements, to support project progression and product release.
•Review & approval of documentation for early development (route 1 & 2) builds ensuring all build checklist requirements and agreed inspections per quote are completed prior to release of product.
•Coordinate Product Complaint(PC) and Non-Conformance (NC) processes and drive timely completion of phases.
•Trouble-shoot quality issues within cross-functional project teams. Apply systematic problem-solving methodologies such as DMAIC and Process mapping.
•Drive adherence to quality standards and the application of risk-based decisions, using tools such as PFMEA and risk assessment.
•Maintain Visual Management boards, quality metrics, reporting systems and prepare required reports, highlighting trends and issues to QE as appropriate
• Conduct internal quality audits to ISO and GMP requirements and provide support for Supplier, Customer and Regulatory audits.
• Develop and deliver training where required across multiple shifts.
• Quality support on cross-functional teams working on process change review and related assessment prior to implementation of change.
•Support to Development Value Stream on item set up and approval processes.
•Updating Project Folders with Quality documents as required to ensure compliance with QMS.
• Project work as assigned.
• Drive full compliance to GDP & GMP requirements.
• Ensure Quality and EHS policies and procedures are always adhered to.

Competency Profile

Professional skills/knowledge
• Diploma in Quality/Engineering / Science or equivalent qualification.
•General understanding of the requirements of a regulated medical device industry.
•Knowledge of quality principles and ability to utilise these in a manufacturing environment.
•Good understanding of structured problem-solving.
• Excellent Computer Skills (Word, Excel, and PowerPoint).
• 2+ year industry experience in a medical device manufacturing environment or similar is desirable.
• Experience within a hands-on line support type role is desirable.
•Understanding of Lean Principles, certified to yellow belt level is desirable.

Personal Skills
•Good administrative/organizational ability with high level of attention to detail.
•Excellent communication (both verbal and written) & interpersonal skills.
•Ability to work in a cross functional team.
•Ability to generate appropriate professional relationships with customers.
•Ability to work on own initiative in a fluid and demanding environment.
•Understanding of Teleflex Quality system is desirable
•Knowledge of Teleflex processes and products is desirable.

Teleflex is an equal opportunity employer.  Applicants will be considered without regard to age, gender, race, civil status, family status, sexual orientation, disability, religion and/or membership of the traveller community.   If you require accommodation to apply for a position, please contact us at talent.emea@teleflex.com.

Diversity fosters innovative thinking and entrepreneurship and that’s what we are about at Teleflex.  We trust and value our people and their diversity and we make it fun to work here.  We are on a journey to ensure our workplaces mirror the patients we serve and the communities we operate in.Our approach is simple, we embrace everyone and want them to feel they belong here.We are building a culture where all employees can bring their best and unique selves to work.If that appeals to you, we would love to hear from you. Come join a company where diversity is sought out and inclusivity is how we progress.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.