Regional Director of Quality - US Quality Operations

Date: Sep 15, 2022

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel: Up to 25%

Requisition ID: 7038

 

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

•    QA/RA is a complex and diverse organization within Teleflex which is responsible to ensure products are fit for purpose and meets all regulatory requirements.  
•    This position is responsible for US QA Operations (Manufacturing facilities) and will be based in Maple Grove, MN or Morrisville, NC, with up to 20% travel.
•    The role requires a senior strategic leader and technical expert with the ability to manage a broad set of activities as described below.
 

Principal Responsibilities

•    Leads a diverse group of employees by sustaining an inclusive and empowered organization which is constantly developing and adapting to the current and emerging business needs.
•    Provide expert opinion, advice and recommendation to the Global Vice President QA (Manufacturing)
•    Responsible to ensure compliant quality systems that meet the business needs at US 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 product QA activities at US Manufacturing facilities, including the day-to-day manufacturing and product quality, regulatory body audits and post market surveillance.
•    Leads the combined regional team within US Manufacturing Quality to establish and maintain the Quality System policies, procedures, work instructions and training associated with the global operational strategy.
•    Manages and supports Quality Improvement projects in all areas of responsibility. Constantly delivers improved value for all stake holders by driving and developing a culture of excellence through continuous improvement.
•    Supports Supplier Quality Management and partnership with Operations Procurement and Global Supplier Quality teams. Supports Sterilization, Microbiology and partnership with Operations and Global Sterility Assurance team.  
•    Sets technical direction for QA in collaboration with US Manufacturing sites and business partners. 
•    Serves as strategic member of the QARA Global team.
•    Provide leadership to all groups that report into the position and actively drives key talent development through coaching, mentoring, development assignments and other formal and informal actions and systems.
•    Ensures the focus of every employee within the US manufacturing sites 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.
•    Ensure that necessary legal, regulatory and corporate compliance systems are in place and adhered to.
•    Define and recommend goals and objectives in each area of responsibility. Develop specific short-term and long-term plans and programs, together with supporting budgets.
•    Provide other departmental 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.
 

Education / Experience Requirements

•    Bachelor of Science degree in an engineering, medical or science discipline is a minimum requirement. Advanced degree preferred.
•    A minimum of 15 years’ leadership experience in the medical device industry, with at least 10 years’ experience in regulatory and/or quality function(s) commensurate with responsibilities outlined above.
•    Experience of multi plant operations with regard to compliance with US Quality System Regulations, ISO 13485 and other International requirements
•    Extensive knowledge and understanding of the 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.
•    Proven audit experience for various regulatory bodies.
•    Extensive experience in a matrix management organization is a must.
•    Must be fluent in English (Native or bilingual proficiency).
 

Specialized Skills / Other Requirements

Lead
•    Has a Sense of Purpose & Inspires others
•    Has a desire & ability to “step up”
•    Takes accountability
•    Demonstrates critical judgement 

Engage
•    Communicates with Impact
•    Builds and sustains relationships 
•    Plans and Organizes 
•    Is present & available 

Develop
•    Develops Leaders
•    Builds High Performance people & teams
•    Invest in personal growth 
•    Develops Organization capability

Improve 
•    Creates value for the customer 
•    Demonstrates Continuous Improvement via results. 
•    Creates a culture of inclusion & involvement
•    Makes the tough calls when organizations are not performing 

Demonstrates Functional Mastery
•    Extensive knowledge and understanding of US and international medical device regulations, standards and 
     guidance documents.
•    Strategic Agility and Customer focus: converts strategies to tactical actions and objectives for the organization to
     deliver value to the customer.
•    Knows the Regulatory environment.
•    Complex technical problem-solving skills/good analytical skills/data driven.
 

#LI-DR1

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.

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.

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