Job Description Summary

This position leads the local sterilization processing site. The Sterilization Supervisor serves as the Quality representative for the site and is responsible for ensuring the quality system meets all applicable regulatory standard, develops, and implements programs or processes to establish and maintain quality standards of existing products and services, policies, procedures and methods to check product and processes pertaining to sterilization.

The Sterilization Supv. also has the responsibility and duty to put any product on hold that is identified as potentially non-conforming and escalating as needed for additional reviews by technical teams and Sterilization Site leader (SME).

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. 

Responsibilities include but are not limited to:

• The administration and/or coordination of sterilization services at the sterilization site.

• May set production/sterilization schedule based on product, equipment, materials, staffing resources, and volumes to meet demand and to ensure maximum production quantity and quality.

• Coordinate and supervises the daily activities of business support, technical or production.

• Maintains monitoring and cycle development programs for the irradiation sterilization processes that complies with internal/external requirements.

• Develops and implements corrective action programs for deviations to sterilization specifications.  Communicates sterilization process deviation that impact the MDS-IPD Sterility Assurance Program to Sterilization Assurance Team.

• Monitors the operation of the Sterilization department to ensure accurate dosimetry and maintenance of the integrity of the Sterility Assurance Program in accordance with current sterilization and dosimetry standards.

• Applies expertise to solve standard and non-standard problems within the process.

• Responsible for oversight of all product and/or report pre-reviews and releases to the Sterilization Assurance team.

• Based on facility staffing, the Quality Supervisor may be responsible for executing product and/or report releases for all processing runs/lab samples containing a non-conformance, including leading the associated non-conformance investigations.

•  Reviews and recommends approval for protocols and final reports generated by the Sterilization Assurance Team.

• Reviews the current quality system and recommend / implement improvements as needed. Develops analyses and reports on the performance of the quality system. 

• Uses data to perform statistical analysis and recommend process changes to improve service quality.

• Supports internal and external quality system audits including regulatory authorities, notified bodies and customers, as applicable.

• Leads process and product corrective actions and problem-solving activities.

• Collaborates with other departments and facilities within the company on quality related issues

• Overall responsibilities include commitment to ensure external and internal requirements are met according to documented policies, procedures, standards and regulations.

• Perform all other duties as assigned. 

EXPERIENCE:

• 5 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.

• 5 years of experience with medical device or other regulated industries preferred.

• 5 years of experience working in an ISO certified environment required.

• 1-2 years supervisory/project leadership/oversight required

• Familiar with sterilization concepts.

• Exposure to production environment

• *Sterilization experience in Radiation is a plus.

COMPETENCIES:

• Ability to read, analyze, and interpret technical procedures and regulations.

• Ability to write reports and procedures and effectively present information and respond to questions from internal customers and teams.

• Ability to solve practical problems and deal with a variety of situations.

• Effective communication and writing skills for all levels in the organization.

• Must have strong knowledge of operations.

• Demonstrated ability to drive continuous improvement, growth and manage to achieve metrics.

• Strong communication skills with the ability to interact effectively with frontline employees, peers, and leadership.

EDUCATION:

• Bachelor's Degree in Engineering or Science field.

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 AZ - Nogales

Additional Locations

Work Shift