Senior Supplier Quality Engineer (SPP-288)

Date: 16-Feb-2021

Location: Kamunting, 08, MY

Company: Teleflex

Expected Travel: Up to 25%

Requisition ID: 3441

 

About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

 

Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

Principal Responsibilities

1.    Provide supplier quality engineering support for Product and process transfer program, ensuring that all activities are completed and documented in accordance with transfer objectives.
2.    Application of a prioritized approach in achieving key opportunities in quality, service and cost.
3.    Support the development and implementation of appropriate supporting documentation, SOPs and process work instructions compliant with current Good Manufacturing Practices (GMP)
4.    Conduct Gauge R&R studies for supplier quality process between sending and receiving sites.
5.    Transferring and implementing processes, from the sending to receiving facility.
6.    Provide Supplier Quality support for Process validation for products and processes; VP, IQ, OQ, PQ and associated documentation.
7.    Responsibility for projects work streams as assigned by the company, including the scoping, approval, budgeting, specification, execution, qualification and handover as appropriate.
8.    Actively interfacing with cross-functional team members and 3rd party Vendors, and always practicing good teamwork in support of the day to day operating requirements, and in pursuit of achieving the project and business targets
9.    Perform supplier facility compliance audits
10.    Ensure compliance with each company's procedures, cGMP, recognized quality standards and regulatory expectation
11.    Take part in knowledge-transfer activities, including collaborative meetings with other groups
12.    Proven Project Management skills through the delivery of business-critical projects.
13.    Strong communication and influencing skills with both internal and external agents.
14.    Capable of technical leading, influencing and providing technical direction to Engineers, Co-Op Students, Technicians and Operators as required.
15.    Capable of working as part of a multi-disciplined team in a dynamic and results motivated environment
16.    Demonstrable analytical & problem-solving skills, a process improvement orientation, and the ability to handle multiple tasks in a fast-paced and results-oriented environment
17.    Demonstrable ability to work autonomously
18.    A team player, with a flexible approach.
19.    Confident and effective decision maker, with a proven ability to negotiate and influence others.
20.    Provide Lead Auditor accountability within the audit program.  
21.    To serve as subject matter expert in the area of problem-solving methodologies.
22.    Provide training to different levels of the organization on problem solving methodologies/root cause analysis and to develop investigation skills.
23.    Provide other departmental support requested by immediate supervisor.
24.    Adhere to and ensure the compliance of Teleflex Code of Conduct, all Company policies, rules, procedures and housekeeping standards.
25.    To ensure the implementation and maintenance, within the department, of an effective management for occupational safety and health consistent with the Occupational Safety and Health Act 1994 and other legislative requirements.
26.    Ensure Program conforms to the Quality System Regulation (QSR), CMDCAS, MDD 93/42/EEC, ISO 13485 and other relevant Standards. 

Education / Experience Requirements

Qualification    :    •    Bachelor degree in Science, Engineering or any other  technical discipline
Experience      :    

•    Prefer 7-10 years of experience working within regulated industries. Process Engineering experience is highly desirable for the role
•    Product and Process Transfer Experience is desirable
•    Molding Experience highly desirable.
•    Advanced problem solving and root cause analysis.
•    Subject Matter Expert in Purchasing Controls.
•    Advanced statistical techniques knowledge.
•    Minimum 5 years of Lead Auditor experience.
•    Advanced knowledge of ISO 13485 & QSR 21 CFR Part 820
•    3rd party auditor/engineering certification highly desired

Specialized Skills / Other Requirements

Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities may evolve and change over time. 

Teleflex is an equal opportunities employer

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.

© 2021 Teleflex Incorporated. All rights reserved.