Job Description Summary

Develop and sustain quality system processes for the Design Center that complies with applicable regulations and standards, Corporate and Business Platform policies and procedures. Lead an effective Internal Audit Program to identify gaps in existing practices against the policies and procedures and close those gaps.

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, modify and maintain quality system procedures for the design center that comply with ISO 13485:2016 and 21 CFR 820 requirements

• Implement Corporate and Business level Quality System procedures for the design center locations

• Lead or facilitate internal quality system audits per the procedural requirements

• Lead or facilitate MDSAP program

• Lead the management of corporate internal and external audits

• Lead the development of content for the management review process

• Update and report on monthly quality metrics

• Provide inputs on revisions to Corporate and Business level procedures as necessary

• Maintain outsourcing relationships with internal customers and suppliers by management of quality agreements

• Lead or facilitate CAPA – Root cause investigation and implementation of corrective/ preventive actions as it pertains to QMS

Scope of Responsibilities

• Considered as a Subject Matter Expert for QMS processes

• Work is performed without appreciable direction

• Determine and pursue course of action necessary to obtain desired results

Required Qualifications:

• Bachelor’s degree in Science or related discipline or a combination of Associate Degree and 8 years of experience.

• Minimum 5 years experience developing and sustaining quality systems for medical devices, including leading Internal and External Audits 

Preferred Qualifications:

• ISO 13485 Lead Auditor Certification

• Experience within a QMS that transitioned to MDSAP program

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