Quality System Specialist II - Document Control

We are the people who give possibilities purpose

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 Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

The Quality System Specialist II is accountable for support of the continued development, improvement, and implementation of the Quality Systems. This position actively participates in quality guidance, product resolution decisions, Product Development project teams and continuous improvement activities.

Job Responsibilities:

• Supporting the Documentation Management needs for Sustaining Engineering and New Product Development projects. This includes processing of Documents, Engineering Change Orders and Design History Files utilizing SAP software.

• Performing tasks, of moderate complexity, within planned schedules and timelines, supporting document retreival for audits, actively leading or participating on project teams and ensuring documentation compliance.

• Develops solutions to routine assigned activities of limited scope & complexity.

• Follows applicable Company/Unit procedures and may make updates to procedures and policies.

• Works within and across functions for assigned quality system.

Required Qualifications:

• High School Diploma and 10 years experience OR

• Bachelor’s degree in science, engineering, or other relevant discipline and 2 years of relevant experience

Knowledge and

Skills:

• Moderate knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g.
  
  - 21 CFR Part 820, ISO 13485, MDSAP, EU MDR/IVDR).

• Moderate level of application of quality system standards to assigned quality system area.

• Ability to use standard and approved Quality/Compliance methods

• Knowledge in the application of Good Documentation Practices

• Contributes to the completion of milestones associated with specific projects.

• Able to prepare reports, including quantitative/qualitative analysis, summaries, and protocols.

• Able to follow established procedures.

• Able to work within and across functions for assigned quality systems.

• Able to exercise judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions to problems with broad scope and complexity.

• Can develop solutions to routine assigned activities of moderate scope & complexity.

• Able to provide decisions, recommendations, and results that cause moderate progress in project/program goals and schedules.

• Experience with BD software systems utilized in the Quality Systems is desirable (SAP, Docusign, PEGA, Trackwise).

• Must have knowledge/specialization in Documentation Management

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.

At BD, we are committed to supporting our associates’ well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role:

• Annual Bonus
• Potential Discretionary LTI Bonus

• Medical coverage
• Health Savings Accounts
• Flexible Spending Accounts
• Dental…