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Form of workJob Description Summary
The Document Control Manager position at BDPI in Tempe, AZ is responsible for leading the development, implementation, and improvement of the BDPI Business Unit Quality Management Systems (QMS). This includes ensuring compliance with FDA regulations, ISO and other regulatory standards, corporate compliance directives, and customer expectations. The Document Control Manager will collaborate with cross-functional partners to develop policies and procedures, serve as a subject matter expert in regulatory compliance audits and inspections, and liaise with Segment and Corporate on behalf of BDPI. Other key responsibilities include compiling data and analyzing metrics, leading audit actions and CAPAs, and developing documentation. The position requires a Bachelor's degree or equivalent related experience, 5+ years of experience in a documentation-related position at a legal manufacturer, and 5+ years of supervisory experience. Strong communication skills, attention to detail, and the ability to prioritize and organize a busy workload are also required. BD is an equal opportunity employer that values inclusivity and growth-centered culture.
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.
The Document Control Manager is responsible for leading the development, effective implementation, and continuous improvement of the BDPI Business Unit Quality Management Systems (QMS), located at the Tempe, AZ facility. This position ensures that the Document Controls processes are in compliance with FDA regulations, ISO and other regulatory standards, Corporate compliance directives and strategies, as well as customer expectations.
Essential / Key Job Responsibilities (including supervisory and/or fiscal):
Required Qualifications:
Preferred Qualifications:
Education and/or Experience:
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.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization's investment in BD University, you will continually level up your tech skills and expertise.
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 AZ - Tempe Headquarters
Additional Locations
Work Shift
The Document Control Manager position at BDPI in Tempe, AZ is responsible for leading the development, implementation, and improvement of the BDPI Business Unit Quality Management Systems (QMS). This includes ensuring compliance with FDA regulations, ISO and other regulatory standards, corporate compliance directives, and customer expectations. The Document Control Manager will collaborate with cross-functional partners to develop policies and procedures, serve as a subject matter expert in regulatory compliance audits and inspections, and liaise with Segment and Corporate on behalf of BDPI. Other key responsibilities include compiling data and analyzing metrics, leading audit actions and CAPAs, and developing documentation. The position requires a Bachelor's degree or equivalent related experience, 5+ years of experience in a documentation-related position at a legal manufacturer, and 5+ years of supervisory experience. Strong communication skills, attention to detail, and the ability to prioritize and organize a busy workload are also required. BD is an equal opportunity employer that values inclusivity and growth-centered culture.
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.
The Document Control Manager is responsible for leading the development, effective implementation, and continuous improvement of the BDPI Business Unit Quality Management Systems (QMS), located at the Tempe, AZ facility. This position ensures that the Document Controls processes are in compliance with FDA regulations, ISO and other regulatory standards, Corporate compliance directives and strategies, as well as customer expectations.
Essential / Key Job Responsibilities (including supervisory and/or fiscal):
- Lead and develop Document Controls, including the Quality Systems (QS) and Product Realization (PR) aspects of the processes.
- Collaborates with cross functional partners such as Quality Engineering, R&D, Operations, Medical to seek their input into the development of policies and procedures, and their support in addressing Quality Issues.
- Serves as subject matter expert for their designated QMS element in regulatory compliance audits and inspections, as necessary.
- Liaisons with Segment and Corporate on behalf of BDPI, as necessary.
- Maintains the ability to interact with internal/external customers, auditors, and other professionals.
- Supports regulatory inspections and audits, as necessary.
- Compiles data and analyzes metrics associated with the Document Controls processes.
- Leads and drives audit actions and CAPA's associated with the Document Controls processes.
- Applies skills and develops documentation including operating procedures, process flow charts and manufacturing procedures.
- Uses various computer software applications to complete assigned work activities (i.e. MasterControl, TeamCenter, Trackwise)
- Other duties and projects, as assigned.
Required Qualifications:
- Ability to lead a diverse team (entry level to seasoned) through growth and change, including internal and external challenges.
- Experience in electronic document management system, i.e. MasterControl, TeamCenter, TrackWise.
- Advanced language proficiency in reading, writing, understanding, and communicating in English.
- Intermediate to advanced working knowledge of medical device regulations and standards (ISO 13485:2016, FDA QSR, and MDSAP).
- Attention to detail.
- Intermediate computer skills and software applications, including experience with Microsoft Office tools (Outlook, Word, Excel, PowerPoint).
- Excellent oral and written communication skills in English.
- Proven experience in working in a cross-functional team environment as well as the ability to function independently.
- Ability to define and create solutions to challenges or opportunities.
- Ability to communicate with all levels of technical and operations personnel.
- Ability to complete position responsibilities with limited direct supervision.
- Ability to gather and organize information.
- Ability to grasp technical terms, processes, and methods.
- Ability to handle a variety of projects at the same time.
Preferred Qualifications:
- Ability to prioritize and organize a busy and changing workload.
- Ability to troubleshoot system issues without assistance.
Education and/or Experience:
- Bachelor's Degree in a related area or equivalent related experience
- 5+ years' experience in a documentation related position at a legal manufacturer, preferably in an FDA and/or regulated environment.
- 5+ years' experience in a supervisory related position
- Proven ability to prioritize and organize a busy and changing workload
- Proven ability to manage assigned projects with little supervision
- Excellent oral and written communications skills in English
- Excellent Microsoft Word skills
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.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization's investment in BD University, you will continually level up your tech skills and expertise.
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 AZ - Tempe Headquarters
Additional Locations
Work Shift
