Job Description Summary

The Manager, Quality Assurance reports directly to the Associate Director, Plant QA and is responsible for managing the quality activities and personnel for multiple departments in the plant. The manager will coordinate efforts for corrective and preventive action, non-conforming material investigations, and internal and external audits. They will assure manufacturing and support areas are compliant to regulations, standards, and internal procedures. The manager will support continuous improvement activities for the manufacturing and quality systems. They will provide regular updates to management of trends from these areas and oversee training and development activities for quality personnel in area.

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. 

Job Responsibilities:

1.Lead quality activities and compliance programs for multiple departments in the plant including oversight for CAPAs, QNs, temporary deviations, and internal audits.

2. Participate on the plant quality leadership team to ensure compliance for the manufacturing plant to local procedures, regulations, and standards for medical devices and pharmaceutical products.

3. Key member of the quality executive steering committee to drive quality system improvement projects and support individual department and plant continuous improvement goals.

4. Participate as a team member on blitzes, six sigma projects, etc.

5. Responsible for analyzing quality data trends and initiating projects to address deficiencies.

6. Empower quality associates to seek out opportunities to improve quality and compliance.

7. Assist quality engineers, production managers, engineers, and supervisors on identification of root cause of quality problems.

8. Coordinates presentations for management review and platform meetings for areas of responsibility.

9. People leader for quality engineers and other quality personnel (calibration, laboratories, technicians, etc.) as assigned.

10. Coach and mentor quality engineers and other quality personnel in the plant. Assist associate director of quality to support external audits (FDA, ISO, corporate audits, customer audits, etc.).

11. Comply with all local, state, federal, and BD safety regulations, policies, and procedures including RCRA Hazardous waste regulations.

12. Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.

*This is not intended to be an all-inclusive listing of duties.  Other job-related duties may be required.

This position requires:

• Bachelor’s degree with a minimum of 4 years proven experience or a combination of equivalent education and experience Preferred qualifications include:

• Degree in Engineering or Life Sciences

• Six Sigma Certification

• Experience in quality and high speed manufacturing

Critical Knowledge and Skill to perform and deliver to the scope and deliverables of the job:

1.     Extensive application of technical principles, theories, concepts and quality sciences, tools and systems with measurable / confirmed results

2.     Track record of root cause determination and effective corrective / preventive action implementation

3.     Provides training for product development teams and continuous improvement teams on best practices

4.     Conducts audits as member of a quality system audit team (e.g. SME, etc…)

5.     Writes and leads risk management activities including risk management reports and risk analyses

While performing the duties of this job, the employee is regularly required to