Associate Director, Quality Systems & Architecture

Associate Director, Quality Systems & Architecture

The Associate Director, Quality Systems & Architecture will be responsible for leading QMS strategy, including the developing, establishment and maintenance of QMS programs, policies, processes, procedures and controls. This role will lead a team based in San Diego, CA and provide subject guidance for our Tijuana, Otay, Vienna, and other global sites conducting QMS activities.

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 usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto 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.

Responsibilities

This leader must develop strategic quality programs to oversee and foster the following areas and represent QMS expert-level leadership and guidance for a dedicated team.

• QMS architecture : QMS certificate change notifications; change in scope of activities performed at sites; and site transfers
• QMS compliance : front room host for external audits and inspections; QMS expert to prep SMEs for front room; Management Review host; identifying QMS gaps in organizational structure, competency, or technical areas; implementing solutions to close QMS gaps, including but not limited to CAPAs, projects, workshops, and training; authoring CAPA investigations
• QMS harmonization activities : MMS lead for Inspire Quality program to harmonize processes with Global expectations and between MMS platforms (including Class I / II medical devices and non-medical devices)
• QMS integration activities : QMS impact assessments for integrating acquisitions, platforms, products, sites, etc.; due diligence activities for potential acquisitions

Required Qualifications

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

Minimum 10 years experience in Quality, Regulatory, or Operations of a Medical Device, IVD, Pharmaceutical or Biotech firm.

Minimum 5 years experience directly managing Quality professionals.

Demonstrated expert-level knowledge of QMS.

Ability to travel domestically and internationally, up to 25%

Strong leadership skills with demonstrated ability to deliver excellent results

Strong project management, team skills, and influential management

Experience leading or supporting FDA and / or Notified Body inspections

Excellent communication skills (up, down, and outward)

Preferred Qualifications

Experience in Regulatory Affairs preferred.

Experience in metrics, data analytics, and / or statistical analysis preferred.

ASQ certifications CQE, CSQE, CRE, CMQ / OE, CSSGB and / or CSSBB highly desired.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and / or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

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 Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.

Salary Range Information : $169,800.00 - $280,300.00 USD Annual