BD (Becton, Dickinson and Company)
Manager, Quality Assurance
BD (Becton, Dickinson and Company), Sandy, Utah, United States, 84092
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.
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.
Key member of the quality executive steering committee to drive quality system improvement projects and support individual department and plant continuous improvement goals.
Participate as a team member on blitzes, six sigma projects, etc.
Responsible for analyzing quality data trends and initiating projects to address deficiencies.
Empower quality associates to seek out opportunities to improve quality and compliance.
Assist quality engineers, production managers, engineers, and supervisors on identification of root cause of quality problems.
Coordinates presentations for management review and platform meetings for areas of responsibility.
People leader for quality engineers and other quality personnel (calibration, laboratories, technicians, etc.) as assigned.
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.).
Comply with all local, state, federal, and BD safety regulations, policies, and procedures including RCRA Hazardous waste regulations.
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:
Extensive application of technical principles, theories, concepts and quality sciences, tools and systems with measurable / confirmed results
Track record of root cause determination and effective corrective / preventive action implementation
Provides training for product development teams and continuous improvement teams on best practices
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 stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
Work Environment:
1.This position is often in a clean room or laboratory manufacturing environment and the physical demands described are representative of those that must be met by an incumbent to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions (Per the Americans with Disabilities Act of 1990)
The incumbent may be frequently required to stand and/or occasionally sit for extended periods of time.
The position will almost always have exposure to work near moving mechanical equipment, and potential temperature fluctuations.
Occasionally the position will have exposure to fumes, airborne particles, hazardous chemicals, cleaning compounds and solvents.
The incumbent may be exposed to noise levels in the work environment moderate to loud.
The incumbent must be willing and able to wear required PPE such as, safety glasses, face mask and/or shield, hearing protection, safety shoes, hair and beard net and smock.
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 encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Primary Work Location
USA UT - Sandy
Additional Locations
Work Shift
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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.
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.
Key member of the quality executive steering committee to drive quality system improvement projects and support individual department and plant continuous improvement goals.
Participate as a team member on blitzes, six sigma projects, etc.
Responsible for analyzing quality data trends and initiating projects to address deficiencies.
Empower quality associates to seek out opportunities to improve quality and compliance.
Assist quality engineers, production managers, engineers, and supervisors on identification of root cause of quality problems.
Coordinates presentations for management review and platform meetings for areas of responsibility.
People leader for quality engineers and other quality personnel (calibration, laboratories, technicians, etc.) as assigned.
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.).
Comply with all local, state, federal, and BD safety regulations, policies, and procedures including RCRA Hazardous waste regulations.
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:
Extensive application of technical principles, theories, concepts and quality sciences, tools and systems with measurable / confirmed results
Track record of root cause determination and effective corrective / preventive action implementation
Provides training for product development teams and continuous improvement teams on best practices
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 stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
Work Environment:
1.This position is often in a clean room or laboratory manufacturing environment and the physical demands described are representative of those that must be met by an incumbent to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions (Per the Americans with Disabilities Act of 1990)
The incumbent may be frequently required to stand and/or occasionally sit for extended periods of time.
The position will almost always have exposure to work near moving mechanical equipment, and potential temperature fluctuations.
Occasionally the position will have exposure to fumes, airborne particles, hazardous chemicals, cleaning compounds and solvents.
The incumbent may be exposed to noise levels in the work environment moderate to loud.
The incumbent must be willing and able to wear required PPE such as, safety glasses, face mask and/or shield, hearing protection, safety shoes, hair and beard net and smock.
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 encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Primary Work Location
USA UT - Sandy
Additional Locations
Work Shift
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.