Job Description

Expected Travel: Up to 10%

Requisition ID: 8829

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

The QA Director will represent the Quality function as a member of the Kamunting Leadership Team and in doing so, keep the patient at the centre of everything we do. The purpose of the role is to ensure that we strive to improving the health and quality of people\'s lives. The QA Director will ensure that we have the appropriate people, systems, processes, and practices in place to allow the Quality Team to be effective and impactful. The QA Director will drive a culture of Living Quality, high performance, and collaboration across the organization.

Principal Responsibilities

Team Leadership

• Sets out a vision, sense of purpose, strategy and goals and objectives which ensures that the team is focused, aligned, engaged, and empowered to meet the QA and business overall goals.
• Establishes the required governance models and management practices required to ensure that the team meets its goals and objectives.
• Engages with stakeholders in a professional and constructive manner, ensuring that the Quality agenda is understood and appreciated by the wider Teleflex team.
• Drives Talent development through sponsorship, coaching, mentoring, development assignments and other formal and informal actions and systems.
• Ensures that there is a vibrant QA succession pipeline of Talent for critical roles.
• Leads a diverse group of employees by sustaining an inclusive and empowered team which is constantly developing and adapting to the current and emerging business needs.

Quality Management

• Responsible to ensure compliant quality systems that meet the business needs at APAC manufacturing facilities. Quality system documentation should meet the requirements of 21 CFR Part 820, ISO 13485, the European Medical Device Directives/Medical Device Regulation, the Japanese Pharmaceutical Affairs Law, and other international quality system regulations and standards as appropriate.
• Responsible to manage and oversee all product QA activities at the Kamunting Site
• Sets strategic direction for QA in collaboration with the Kamunting manufacturing sites and business partners.
• Ensures that the appropriate budgets, resources, systems and processes are in place with the purpose of putting the patient at the centre of everything we do, while continuing to incorporate broader business goals.
• Provide expert opinion, advice and recommendation to the APAC QA Director.
• Serves as member of the Regional QARA Site team and the Kamunting Leadership team.
• Ensures the focus of every employee within the site is delivering the highest product and service quality standards to all our customers and their patients in a consistent manner and that the systems necessary to do so are in place.
• Provide other support as requested by immediate supervisor.
• Adhere to and ensure the compliance of Teleflex\'s Code of Conduct, all Company policies, rules, procedures, and housekeeping standards.
• Putting integrity as key behavior and taking accountability for quality decision.
• Encourage innovation ideas from team members to make the Quality process more robust.

Education / Experience Requirements

• Bachelor of Science degree in an engineering, medical or science discipline is a minimum requirement. Advanced degree preferred.
• A minimum of 8 years\' leadership experience in the medical device industry, with at least 12 ~15 years\' experience in regulatory and/or quality function(s) commensurate with responsibilities outlined above.
• Extensive experience of compliance with US Quality System Regulation (21 CFR Part 820), Medical Device Directive/Medical Device Regulation and the ISO 13485 quality system requirements.
• Extensive knowledge of quality techniques and practices, as they relate to the medical device industry.
• Track record of developing Organisational capability through people, systems and process development.
• Experience of working in a dynamic, multinational matrix environment.
• Strong business acumen and an ability to influence the direction of the company.
• Audit experience for various regulatory bodies is desirable but not essential.
• High level of English (Native or bilingual proficiency).

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\xc2\xae, Deknatel\xc2\xae, Hudson RCI\xc2\xae, LMA\xc2\xae, Pilling\xc2\xae, R\xc3\xbcsch\xc2\xae, UroLift\xc2\xae and Weck\xc2\xae - trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, R\xc3\xbcsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

Teleflex