Job Description Summary
This position is the supervisor of the Quality Technicians for a department, who will manage the Quality function in a particular manufacturing area. Develop and maintain quality control plans; deal with non-conforming material, customer complaints, and CAPAs; provide quality metrics to Manufacturing and Quality management; assure the manufacturing areas are compliant to required regulations; and support continuous improvement activities.
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.
Responsibilities:
1. Supervise the Quality Technicians of the department to ensure Quality Assurance is operating efficiently and that product is contained as needed.
2. Mentor and train quality technicians and operations in performing inspections, documentation, and control of non-conforming material.
3. Support the implementation of new processes and changes by developing quality plans, approval of validation plans and protocols, inspection methods, work instructions, and raw material specifications and inspection plans.
4. Analyze and interpret inspection and process data to identify and prevent quality problems and continuous improvement opportunities.
5. Responsible for the investigation, documentation, root cause, and corrective action activities of deviations and non-conforming material.
6. Responsible for the investigation, documentation, root cause, and corrective action activities of customer complaints.
7. Support manufacturing and quality process improvement projects as an effective team member or leader using Continuous Improvement and Six Sigma tools.
8. Develop working knowledge of applicable regulatory, Corporate and/or Unit requirements.
9. Facilitate Change Control.
10. Communicates across functions / departments for assigned areas of responsibility.
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.
Other duties as assigned.
Requirements:
1. Requires a Bachelor's degree and a minimum of 2 years experience, or
2. A minimum of 6 years relevant experience, or
3. A combination of education and relevant experience.
Preferred Qualifications:
4. 1 year of direct supervisory experience of technical professionals.
5. Leadership experience, Project management and advanced communication skills.
6. Medical device or pharmaceutical experience.
7. ASQ certified quality technician (CTQ) or ASQ QE certification.
8. Experience with analytical problem solving skills, technical writing skills, automated documentation systems and root cause analysis.
9. Continuous Improvement experience and Six Sigma Green Belt certification/training.
10. Process validation, Design of Experiment (DOE), 21 CFR 820-21/211 cGMP, ISO 13485-9001 experience.
11. Experience with Minitab, SAP, and Trackwise.
12. Knowledge of applicable regulatory requirements.
Knowledge and Skills:
1. Quality Control
2. Knowledge of applicable regulatory requirements
3. Process Validation
4. Root Cause Analysis
Work Environment:
1. This position is 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.
2. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions (Per the Americans with Disabilities Act of 1990)
3. The incumbent may be frequently required to stand and/or occasionally sit for extended periods of time. Bending, stooping and reaching are also frequently required.
4. While performing this job, the employee is regularly exposed to episodes of walking, kneeling, balancing, crouching, pushing/pulling, repetitive grasping, hearing, twisting, lifting, frequent use of hand to finger, handle, feel, pick or type which can include repetitive motion of the wrists, hands or fingers.
5. The position will almost always have exposure to work near moving mechanical equipment, and potential temperature fluctuations.
6. 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.
7. The incumbent must be willing and able to wear required personal protective equipment (PPE) such as safety glasses, face mask and/or shield, hearing protection, safety shoes, and clean room attire such as hair net, beard cover, and smock.
*This is not intended to be an all-inclusive listing of duties. Other job-related duties may be required.
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.
PDN
Primary Work Location
USA UT - Sandy
Additional Locations
Work Shift
US BD 1st Shift 8am-430pm (United States of America)