Job Description Summary

The Associate Manager Quality will play a key role in managing the Process Quality work groups. The dynamic work group operates in a fast-paced environment; the In-Process Quality group, whose core responsibilities include finished product inspection and associated documentation, as well as review of manufacturing (DHR) records and product release decisions. The Associate Manager Quality will have an integral role in helping design the vision and strategy of the local Quality Leadership Team and reports directly to the Plant Quality Manager. The position has the opportunity to interface and collaborate with BD associates worldwide.

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

• The essential functions of this position include but are not limited to:

• Responsible for the operation and supervision of the work group in support of a multiple shift manufacturing operation.

• Ensures that required testing is performed, documented, and maintained per applicable procedures to support the disposition of raw materials and finished product.

• Conducts data trending (ie Right the First Time, quality notifications) and coordinates/leads improvement efforts associated with the trends.

• Assures compliance with internal and external regulatory agencies (OSHA, EPA, FDA, etc.) by developing, implementing and reviewing local procedures and policies.

• Establishes, facilitates, and reviews training programs to ensure compliance with company policies/procedures, good laboratory practices and current Good Manufacturing Practices (GMP’s).  Assures cross training of personnel is conducted, as needed, and monitors that progress.

• Oversees the preparation of the work group’s budget.  Assures that necessary capital requests are submitted annually.

• Executes and/or approves study/validation protocols for projects associated with the work group.  Monitor progress on projects, validations and studies assigned to the work group.

• Provides management with technical input associated with disposition of nonconforming components and manufactured products.

• Supports investigations pertaining to testing and dispositioning of components and finished product, product complaints and other investigations. 

• Coordinates testing support (ie Chemistry) for contract plants.

• Responsive to changes within the medical device industry, including regulatory implications.

• Ability to plan for the future of the work group, including people, resources, equipment, and layout.

Supervision

• This position reports directly to the Plant Quality Assurance Manager

• This position has direct reports

MInimum Requirements

• B.S. or B.A. from an accredited institution in a science-related field, such as Chemistry, Biology, Quality Assurance, Engineering, Mathematics/Statistics or equivalent.

• Minimum of 3-5 supervisory experience required.

• Proven track record of supporting and driving continuous improvement activities in a production environment is highly desired.

• Working knowledge of QSR’s/ISO 13485 desired.

• Knowledge of inspection methods and procedures desired.

• Working knowledge of validation (IQ, OQ, PQ) and designed experiments desired.

• Working knowledge of Six Sigma and statistical tools such as control limits and trending is desired. 

Mental Requirements

Strong verbal, written, analytical, persuasion and interpersonal skills.

• Strong communication skills, with focus on teamwork and leadership. 

• Willing to work collaboratively to identify developmental opportunities for team members.

• A positive attitude, willing and able to learn.

• Strong organizational skills.

• Able to network both within and outside the organization.

• Ability to accept responsibility and perform duties with little or no direct supervision.

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. 

PDN

Primary Work Location

USA NE - Broken Bow

Additional Locations

Work Shift