Sr Dir, Platform Quality Management - Vascular

BD; United States; Remote; USD 10,000 - 60,000; Full time

Job summary

An established industry player is seeking a Sr. Director of Quality to lead their QA functions across global sites. This pivotal role involves ensuring compliance with quality management systems, overseeing a team, and collaborating with various departments to drive regulatory strategies. The ideal candidate will have extensive experience in the medical device industry, particularly in leading FDA inspections. Join a company that values your contributions and fosters a culture of growth and innovation, where you can make a significant impact on health solutions worldwide.

Qualifications

• 10+ years leading a QA organization in the Medical Device Industry.
• Experience with FDA or Notified Body inspections.

Responsibilities

• Lead the Platform QA organization to ensure compliance and quality.
• Manage QA budget and collaborate with various departments.
• Provide leadership during FDA inspections and resolve quality issues.

Skills

Leadership

Quality Assurance

Regulatory Compliance

Collaboration

Strategic Agility

Problem Solving

Business Acumen

Talent Development

Education

BS degree in a technical field (Engineering, Science, Math/Stat)

Job description

Job Description Summary

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.

The Sr. Director of Quality will be responsible for the platform QA functions. This role will lead a team and provide subject guidance for our global sites. The Sr. Director of Quality will be a member of the Platform Quality Leadership Team. As such they will work with those leadership teams to set platform strategies, allocate resources, and set priorities. They will ensure quality management system and product quality issues are appropriately identified and managed across the platform.

Responsibilities:

1. Ensure the Platform QA organization has the capabilities to execute on the business strategies and maintain substantially compliant Quality Systems.
2. Responsible for QA budget and expenditures.
3. Work closely with leaders in Operations, Regulatory Affairs, Medical Affairs and others to create and execute regulatory strategies.
4. Must have the ability to understand the technical aspects of the BD PI products.
5. Ensure that the compliance of the QMS is maintained at a high level.
6. Provide leadership during FDA and notified body site inspections as needed.
7. Partner with Regulatory Affairs in interfacing with the FDA on Post Market issues.
8. Ensure the design assurance teams are provided with the necessary resources. Ensure that escalated quality issues are appropriately addressed.
9. Provide leadership to Operations and Operations Quality Engineering to resolve quality issues. Oversee and support the QA functions in decisions regarding ship holds.
10. Works with R&D and Operations to solve field quality issues.
11. Ensure the QA functions are supporting the product development programs and that the development processes are compliant to applicable regulations.
12. Develop the staff to realize their full potential by setting expectations, coaching, hiring great talent, and managing staff performance.
13. Lead and develop a cross functional team to develop a global remediation strategy, where applicable, that is executed on-time and aligned with FDA standards.

Education and Experience

1. BS degree in a technical field (Engineering, Science, Math/Stat)
2. At least 10 years’ experience leading a QA organization in the Medical Device Industry
3. At least 5 years’ experience leading FDA or Notified Body inspections

Minimum Qualifications:

1. Ability to effectively collaborate with other leaders in a highly matrixed organization
2. Demonstrated customer centric behaviors to drive a culture of engagement and successful business growth.
3. Establishes leadership credibility based on integrity, ownership of a decision, and a track record of achievement in delivering large and/or multiple complex projects and influencing business outcomes.
4. Solid business acumen and knowledge of medical device and/or life sciences market environment.
5. Demonstrated strategic agility to develop and implement business strategies and implement innovative problem-solving approaches to deliver results.
6. Optimized execution: Good planning and organizational skills and ability to accelerate the pace of completing priorities to meet or deliver earlier than customer expectations.
7. Global and Collaborative: Ability to work across all regions globally at both an executive and tactical level. Can operate successfully in a multi-matrix business environment.
8. Effective Talent Development: Proven track-record of developing others in a cross functional team environment and maximizing resources provided. Takes action to assure organizational capabilities are in place to achieve strategy and develop a strong succession candidate pool of leaders at all levels.
9. Exhibits leadership courage and agility in leading problem resolution and decision making.
10. Must have the ability to travel, including internationally, as needed to support the business.

Preferred Qualifications

1. Experience with product lines related to oncology and/or vascular within medical device

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.