Quality Assurance Manager

Job Description Summary

The Quality Assurance Manager is responsible for strategic oversight and leadership direction within the Production QA function to include In-Process Inspection, Finished Goods Inspection, Final Product Release, Quality Engineering, Supplier Quality while maintaining full compliance with FDA Quality System Regulations (21 CFR Part 820), all applicable International Standards (i.e. ISO 13485, MHRA GMPs, etc.) and BD policies/procedures.

Associate provides business, technical, and production support, as required; provides technical guidance to employees, as required; develops processes and procedures; has in-depth Quality Assurance expertise.

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 Med Tech 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.

• Effective implementation of the site QMS
• Responsible for strategic oversight and leadership direction of In-Coming Inspection, In-Process Inspection, Finished Goods Inspection, Final Product Release, Quality Engineering, Customer Complaint Investigation and Supplier Quality.
• Knowledge of FDA regulatory requirements (QSRs – 21 CFR Part 820)
• Knowledge of International regulatory requirements (ISO 13845, MHRA GMPs, etc.)
• Responsible for Production and Process Controls from a Quality perspective
• Serves as a technical resource for all QA activities
• Identifies data requirements, often beyond the standard, and collects all relevant data needed to analyze a complex problem, situation or issue
• Advises others on a variety of topics within own functional area
• Tracks internal trends and suggests process improvements based on observations
• Leverages the appropriate resources to provide solutions for internal/external customers
• Applies hypotheses and an understanding of cause and effect when analyzing a complex process, situation or issue or discerning data patterns
• Identifies implications/conclusions from the logical analysis of a complex situation or issue
• Serves as the QA subject matter expert (SME) for internal/external regulatory compliance audits
• Drives team to achieve established goals in proactive and pragmatic manner; adjusts plan of action accordingly to maneuver obstacles and achieve success
• Manages budget for own area, allocates resources and delegates accordingly, applying knowledge of profit drivers within own area / department

• Education:
  
  Bachelor of Science degree in an engineering or related field.
• Minimum 7 years' experience in quality, with at least 3-5 years in the medical device industry or pharmaceutical industry.
• Minimum 2-3 year's management experience
• Experience in interface with Domestic and Foreign government agencies. (managing audits, Front room experience)
• CAPAs and validation.

• Experience with SAP preferred
• Experience in Lean/Six Sigma preferred
• Computer proficiency in Microsoft Office (Word, Excel, Power Point, Project, and Outlook)

• Must be able to lift, push/pull, and carry up to 25 pounds
• Must be able to wear appropriate personal protective equipment as required
• Position requires sitting or standing for long hours
• Use of hands and fingers to manipulate office and calibration equipment is required

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…