Job Description Summary

The Quality Manager is responsible for strategic oversight and leadership direction within the Production QA function to include: In-Coming Inspection of all raw materials, In-Process Inspection, Finished Goods Inspection, Final Product Release, Quality Engineering, Customer Complaint Investigation, Supplier Quality and Calibration/Metrology 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. This position will be the lead Quality representative for a class 3 legal manufacturing site.
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.

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. 

Summary

The Quality Manager is responsible for strategic oversight and leadership direction within the Production QA function to include In-Coming Inspection of all raw materials, In-Process Inspection, Finished Goods Inspection, Final Product Release, Quality Engineering, Customer Complaint Investigation, Supplier Quality and Calibration/Metrology 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.  This position will be the lead Quality representative for a class 3 legal manufacturing site.
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.

Salary Range- $121,100 - $199,800

Duties and Responsibilities

• 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, Supplier Quality and Calibration/Metrology

• 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) and lead 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.

 

Qualifications

• 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 Pharma.  Understanding of Class 3 medical device standards and regulatory implications preferred

• Minimum 2-3 year's management experience

• Experience in interface with Domestic and Foreign government agencies.

• Experience with SAP JDE, Teamcenter and other quality platforms preferred.

• Experience in Lean/Six Sigma preferre