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, QuikClot, LMA, Pilling, 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.
Position Summary
Quality Lead for all phases of product realization including NPD, NPI, Commercialization, Sustaining and End of Life. To bring creative, innovative and sound Quality decision making to the team, ensuring effective implementation of the required QMS documentation, and professional communication with all Stakeholders. Quality oversight on problems of diverse scope including complaint & NC investigations, demonstrating good judgment in selecting methods and techniques for obtaining solutions, driving corrective actions & verifying effectiveness for assigned area. Oversee QA inspection, testing & release. Guides, supports and trains other quality team members.
Key Responsibilities
1. Monitor and drive compliance within the development process and/or operations to GMP and the requirements of the QMS within assigned area.
2. Troubleshoot quality issues identified during product development and commercialization and drive solutions to reduce non-conformances.
3. Provide quality input and guidance on Validation planning and documentation utilizing risk-based (pFMEA) decision making and driving risk mitigation activities into process development and product quality assurance.
4. Lead vendor and part appraisal and approval processes.
5. Lead process change and related assessment and implementation of change notification.
6. Work with project team in the identification and implementation of appropriate statistical techniques and visual control systems to monitor the manufacturing processes.
7. Ensure that appropriate quality plans, test methods, test plans, deviations, work instructions, specification and drawings are in place and being adhered to during product development, manufacturing transfer and commercialization.
8. Understand and lead specification reviews, factoring in Teleflex capabilities, and drive alignment with customer on acceptance criteria ensuring Teleflex and Customer specifications/ drawings are aligned.
9. Ensure that all design/specification/process changes are in line with customer contractual agreements and product safety while facilitating progressive and efficient change management.
10. Oversee product testing and release activities, including disposition of non-conforming material, the identification of scope, control of related NC material, root cause and appropriate CAPA actions and thorough documentation of same within schedule.
11. Establish and monitor process quality performance to determine when improvement actions are appropriate.
12. Act on Customer quality feedback and requests.
13. Review and sign off on QMS documentation and records.
14. Participate or lead cross-functional project teams to eliminate waste and improve performance.
15. Develop and implement programmes to ensure compliance with regulatory requirements and documented controls and procedures within area of responsibility.
16. Provide support for Internal, Customer and regulatory audits.
17. Ensure full compliance with regulatory requirements.
18. Ensure Quality and EHS policies and procedures are adhered to at all times.
19. Complete projects as assigned.
Education / Experience Requirements
1. A seasoned, experienced professional with a full working knowledge of EN ISO 13485 the principles of GMP & FDA QSR 21CFR Part 820.
2. Degree in an engineering/quality or related discipline.
3. Certified QE desirable.
4. Technical report writing.
5. Process validations/FMEA's and protocols.
6. Proficient in Statistical analysis.
7. Structured Problem-Solving techniques – Lean Six Sigma Green Belt desirable.
8. Understanding of Lean Principles.
9. Ability to drive projects to completion.
10. Guided by the disciplines of due diligence and compliance in all aspects of work.
Specialized Skills / Other Requirements
1. Clear verbal and written communication.
2. Ability to lead meetings.
3. Ability to work in a cross-functional team.
4. Ability to influence employees that do not report directly.
5. Self-driven and requires minimal supervision.
6. Ability to understand the key drivers of our manufacturing business.
7. Understand the impact of their job on the key business drivers.
8. Basic understanding of other department's impact on the key drivers and how all departments fit together.
9. Ability to understand customer/vendor relationships.
10. Ability to generate appropriate relationships with customers and vendors.
11. Ability to deal with difficult customer or vendor communications.
12. Ability to influence customers/vendors where necessary.
13. Ability to work in a fluid, demanding environment.
14. Understanding and appreciation of Teleflex ethics standards.
15. Ability to gain technical understanding of Teleflex processes and products.
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