Director of Quality Management System & Compliance

Job Description Summary

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

Position Summary
The Director of Quality Management System is responsible for ensuring that BD PI entities worldwide have a robust quality management system that meets/exceeds the applicable regulatory requirements.
The ideal candidate has previous director experience with an established track record of implementing and maintaining Quality Systems that are substantially compliant, efficient, and effective. The ideal  candidate should have demonstrated success leading cross-functional development, implementation, application, maintenance, and continuous improvement of Quality Systems for medical devices. 
 
Detailed Responsibilities
•    Lead all aspects of the entities globally to seek harmonization across the entities and to drive these systems to meet changing regulatory demands (e.g., MDR).
•    Drive the design, development, and implementation of QMS processes with the business unit and BD corporate objectives.
•    Integrate the business unit QMS into the larger BD QMS and Inspire Quality (IQ) initiatives and seeks to drive QMS efficiency and effectiveness. 
•     Drive Quality Systems strategy as follows:
•    Effective and efficient Quality Management — Ensures the QMS is efficient and does not become an inhibitor to operational effectiveness.
•    Compliance – Ensure compliance with regulatory standards across different sites and entities.
•    Leadership – Leads or influences quality networks, businesses, associates and capital resources toward the effective promotion and alignment of organizational goals to the company’s mission and vision. Demonstrates strong big-picture thinking; effectively integrates and balances long-term opportunities and challenges, with day-to-day activities.
•    Innovation— The PI product development process is conducted under the PI QMS. This QMS must be streamlined to develop new products and change management practices to ensure we deliver a world class customer experience.
•    Growth - Responsible for the effectiveness of the PI QMS. An effective QMS delivers revenue growth and margin enhancement.
•    Lead team of direct and indirect reports to accomplish annual compliance goals established by business leadership.
•    Develop and maintain a program to monitor for global regulatory changes including changes to regulations and regulator interpretation of regulations.
•    Develop and maintain business wide compliance training program. Program consisting of both auditor certification and general compliance/quality training for all associates.
•    Develop and maintain metrics dashboard with key indicators of site compliance/Quality System Maturity.
•    Participate in key advocacy activities which help advance state of compliance of the business.
•    Lead and/or participate in external audits from regulators.
•    Lead and/or participate in development of remediation plans for high-risk compliance issues.
•    Lead and/or participate in efforts to establish improved culture of Quality in the organization.

Education and experience:
•    A minimum of 10 years of experience as either a head of QA for a site/business unit having broad responsibility for QMS process, or as a leader responsible for a corporate wide QMS in a highly matrixed global organization.
•    BS degree in a technical field

Required Qualifications
•    Demonstrate they ability to develop a QMS that is both compliant and efficient
•    Expert knowledge of applicable regulations and standards including FDA QSR, ISO-13485, EU MDD, and EU MDR
•    Excellent verbal and written communication skills and have an ability to influence others in the organization. 
•    Ability to develop a long-term strategy for the QMS and be able to fulfill this strategy
•    Ability to effectively operate in a matrix environment and influence and interact with senior enterprise leaders and functional leaders on a regular basis
•    Experience managing staff, developing future quality leaders and building an organizational culture
•    Knowledge of US and International regulations and standards that apply to the medical device industry 
•    In-depth understanding of the application of quality systems to the medical device industry.
•    Must be willing to travel and engage PI entities worldwide to understand their needs and develop QMS processes that meet those needs.
•    Experience in working directly with Notified Bodies and Regulatory Authorities.
•    Effective analytical, technical, and problem-solving skills.
•    Effective meeting and presentation skills.
•    Self-motivated /directed.
 
Preferred Qualifications
•    Certification in a Quality System Element specialty (e.g ASQ Certified Quality Auditor, Quality Manager, Quality Engineer)
•    TrackWise (or other QMS software), technical writing, auditing experience
•    Advanced proficiency in data analysis tools such as Excel.
•    Prior experience managing external regulatory audits

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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