Job Description Summary

The Staff Quality System Specialist is accountable for the support of the continued development, improvement, implementation of the Quality Management System as well as maintaining compliance to regulations, standards, and corporate requirements. This position is also responsible to define and implement the supplier management activities required to approve site and local suppliers and maintain their approved status through their service lifecycle. This is achieved by providing collaborative support to quality leadership and working with other functions in the organization including Quality Engineering, Research and Development, Regulatory Affairs, and addition to corporate functions, regulatory agencies, and suppliers.

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:

• Develop applicable Site / Unit procedures / work instructions and may make updates to Unit level procedures and policies.

• Serve as Supplier Quality leader for local and/or site-related suppliers (products and services) for multiple sites

  • Support identification suppliers and collaborate with cross-functional team to complete supplier selection process

  • Define and implement optimum supplier approval strategy. Facilitate, manage, and track supplier qualification and approval progress

  • Support Supplier creation/updates in Aravo

  • Manage and maintain Quality Agreements with suppliers, when needed

  • Provide on-going Supplier Quality Assurance support to all existing local and site-related suppliers

  • Collect and archive all relevant Supplier-related documentation

  • Support Supplier Quality performance monitoring.

  • Conduct supplier quality audits / assessments, as needed.

  • Manage changes initiated by suppliers. Coordinate with appropriate cross-functional teams

  • Support QA/QC lab with supplier activities related to product batch release and customer complaints as necessary

• Lead or support problem-solving and root cause analysis activities, as needed. Coach cross-functional teams as a problem-solving subject matter expert.

• Support internal / external / customer audits, including but not limited to hosting, auditing, subject matter expertise, and pre- and post-inspection activities, as needed

• Support activities related to management of Quality Systems processes, content, and electronic tools utilization, as needed

• Track trends of various quality data sources. Analyze and report on metrics.

• Assist with Quality Management Review content and related activities

• Support Site and WW Quality System continuous improvement initiatives

Education and Experience:

• BS degree in in Engineering, Science, or other related discipline

• At least 8 years of medical device, biologic, pharmaceutical, or diagnostic industry experience.

Knowledge and Skills:

• Strong knowledge of US and International regulations and standards that apply to the medical device industry including 21CFR820, ISO 13485, EU MDD/MDR, MDSAP country requirements as well as other requirements applicable to the product

• Auditing experience highly desirable

• Proficient communication, organizational and interpersonal skills.

• Ability to perform multiple tasks simultaneously and prioritize workload with minimum supervision

• Effective technical writing and analytical, technical, and problem-solving skills.

• Collaborative ability to work with diverse cross-functional teams

Work Environment:

• BD is a smoke-free campus.  Smoking and the use of electronic smoking devices, marijuana, or tobacco products are not allowed on BD property, grounds or in the parking areas.  We appreciate your cooperation in adhering to this policy

• False eyelashes, press-on fingernails, and Jewelry is not allowed on the production floor including dermals.  Any associate wearing dermals will be required to cover them while working on the production floor. 

• Shoes are required to be Steel Toe and non-slip for all associates while on the production floor for safety purposes.

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.

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 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.

Required Skills

Optional Skills

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Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information

$130,400.00 - $215,200.00 USD Annual