Job Description Summary

The Sr. Quality Manager is responsible for management, direction, and coordination of all quality and regulatory compliance activities across the site in compliance with world-wide regulations, business strategies, and Customer needs. This includes providing the quality leadership encompassing Quality Systems, Quality Engineering, Microbiology, Metrology, and Sterilization control to ensure that the required production, quality, and regulatory standards are achieved through molding, assembly, packaging, sterilization and product release. Reports to the Medication Delivery and Vascular Care (MDVC) Senior Director of Quality Management in Franklin, Lakes with dotted line reporting to the Canaan Plant Manager.

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. 

Essential functions include but are not limited to:

• Develops and implements strategic direction for the Canaan manufacturing plant consistent with Medication Delivery Solutions (MDS) and BDX quality strategy.

• Provides effective Quality Management leadership to department staff and to the Canaan Leadership to meet quality, business, and organization objectives to the BD Medical: MDS.

• Management representative of the Canaan site with regards to all Quality Systems regulation issues.

• Manages and leads the Quality Systems, Validation and Quality Engineering teams for the Canaan Plant.

• Manages and leads the Microbiology Lab, Metrology Lab, and Sterilization control, encompassing sterile release and sterilization Validation.

• Provides effective leadership in teamwork development, effective communication, and quick responses to Customers. Drives continuous improvement in customer satisfaction.

• Implements effective CAPA process focused on reduction of causes of customer complaints, non-conformances, rejections.

• Assesses and builds organization capability for Quality Management, particularly in the identification and mentoring of dedicated high performer individuals.

• Evaluates, facilities, designs, implements, and continually improves quality systems and business process including product controls to achieve quality goals and to maintain a high level of regulatory compliance.

• Appropriately evaluates the regulatory and Quality management competencies and capabilities of the Canaan site

EDUCATION

• Four-year college degree (BA or BS) preferably in the Science or Engineering discipline. Advance degree in the engineering, business, or related field preferable. Broad background in applied statistics process controls, Six sigma is desired.

EXPERIENCE

• Minimum 8 years relevant experience in Quality on manufacturing of medical devices.

• Minimum 6 years of people management experience

• Working knowledge 21CFR820, ISO13485, Risk Management and Change Controls

• Analyze multiple causes and develop creative solutions to complex problems

• Strong verbal, writing and interpersonal skills

PREFERRED QUALIFICATIONS

• Experience on design of experiments and statistics, preferred

• Knowledge of Six Sigma methodology preferred.

• Knowledge of design control principles.

• Ability to function with minimal supervision and to perform several tasks simultaneously with a high level of accuracy.

• Project management experience desired

SUPERVISION

Manages subordinate managers and/or experienced specialist employees who exercise significant latitude and independence

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.

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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Primary Work Location

USA CT - Canaan

Additional Locations

Work Shift