Quality Engineer, Design Assurance

Teleflex; Kamunting; On-site; MYR 150,000 - 200,000; Full time

Job summary

A global medical technologies company located in Malaysia is seeking a qualified candidate for a role within Global Operations. The ideal candidate will partner with R&D and other departments to ensure quality and compliance throughout product development. Responsibilities include creating risk management files, analyzing post-market data, and ensuring adherence to quality management practices. This role demands proficiency in statistical techniques and a solid understanding of applicable regulations, fostering a commitment to continuous improvement in healthcare solutions.

Qualifications

• Ability to analyze data and draw statistically supported conclusions.
• Experience with risk management frameworks and practices.
• Understanding of quality management systems and compliance regulations.

Responsibilities

• Partner with teams for Value Engineering projects in product design.
• Create and maintain comprehensive risk management files.
• Analyze post-market surveillance data to update risk profiles.
• Ensure compliance with quality management system practices.

Skills

Quality tools and statistical techniques

Risk management

Cross-functional collaboration

Usability engineering

Education

Relevant degree (e.g., engineering or life sciences)

Job description

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. 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.

• Partner with R&D, Marketing, Regulatory Affairs, and Operations to support Value Engineering projects in product and process design such as design verification, design validation, design reviews, design transfer, and all other aspects of a design history file.
• Create and maintain risk files consisting of, but not limited to, risk management plans, hazard and risk analyses, failure mode and effects analyses, and risk management reports to assess the risks associated with a product impacted by the Value Engineering Project.
• Analyze post-market surveillance data periodically throughout a product’s lifecycle to update the risk file and reflect its current risk profile. Support Clinical and Medical Writers in analyzing available clinical data, as required.
• Use appropriate quality tools and statistical techniques to collect and summarize data, draw conclusions with confidence, determine sample sizes, apply data distributions, identify relationships between variables, calculate reliability, design and analyze experiments, determine process and performance capability, and make statistically supported decisions.
• Apply the most relevant and useful quality philosophies throughout Design Control and its related processes for both new product development and sustaining. Understand and manage work to minimize cost of quality throughout the product lifecycle.
• Ensure compliance with all practices related to the Quality Management System. Ensure comprehensive documentation is available, adequate records are produced, and change management is implemented.
• Interpret customer feedback to define user needs and product requirements as part of a cross-functional team.
• Understand applicable external regulations and internal standards that drive compliance and apply them in daily function.
• Partner with Usability Engineering SMEs and R&D to assess usability engineering requirements of product and packaging throughout design and development.
• Participate in the review and approvals of biocompatibility and clinical evaluation plans/reports.
• Perform gap assessments on relevant standards/regulations when necessary.
• Execute assigned projects, perform design assurance-related verification testing, and report if required.
• Partner with R&D to review and approve material assessment documentation related to Value Engineering Projects.
• Partner with R&D to review impact test methods for Value Engineering Projects and advise on suitable test methods to be conducted accordingly.
• Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries.
• Define, identify, and apply product and process control methods such as developing control plans, identifying essential design outputs and critical control points, and developing and validating work instructions.
• Apply concepts of producer and consumer risk and related terms, including operating characteristic curves, AQL, LTPD, AOQ, AOQL, etc. Interpret and select variable, attribute, zero-defect sampling plans.
• Apply supplier management principles and provide input on projects for supplier selection, quality expectation letters, supplier quality agreements, and process qualifications.

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.