Be part of something bigger at BD. Here, you’ll join a driven, agile engineering team working in a startup-like environment that has the backing and resources of a Fortune 500 company. In engineering, you could be involved in everything from operations, production and construction to information technology and maintenance environments, all while analyzing and developing solutions to further our engineering capabilities. You’ll use your talent and track record of solving complex problems to achieve one singular goal: advancing the world of health™. At BD, you can make a true difference of one.
Job Description SummaryThis position employs an individual with quality engineering experience in the medical device industry. Main functions of this position will require administrative involvement in the creation, implementation and maintenance of Tepha’s Quality System, and technical involvement in developing process controls in the manufacturing environment. This is a hands-on position requires an excellent understanding of FDA’s Quality System Regulation (QSR), and ISO 13485 and EU MDR 2017/745.
Be Part of Something Bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
This position employs an individual with quality engineering experience in the medical device industry. Main functions of this position will require administrative involvement in the creation, implementation and maintenance of Tepha’s Quality System, and technical involvement in developing process controls in the manufacturing environment. This is a hands-on position requires an excellent understanding of FDA’s Quality System Regulation (QSR), and ISO 13485 and EU MDR 2017/745.
Will provide direction and control of the following:
Review and/or create policies, procedures and work instructions relating to the quality system
Review validation protocols and reports; and assist engineers in the creation of such documents.
Support the CAPA and Internal audit processes.
Support Internal Inspection and Test programs, as well as other areas of the quality system as assigned.
Support the product development and manufacturing process activities as assigned
May support supplier audits
May perform complaint investigations
Knowledge, Skills & Abilities:
Excellent understanding and practical application of medical device quality system regulations with a particular focus on the following:
Inspection & Test
Experience participating in FDA and Notified Body inspections
Excellent written and verbal communication skills
Strong PC skills
Statistical techniques and data analysis
Years of Experience:
A minimum of 5 years in medical device Quality with at least 4 years in an Engineering role
A minimum of a 4-year degree, preferably in an engineering or science field.
ASQ certification (e.g. CQA or CQE) or other professional certifications a plus
Manager, Quality Assurance
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 empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do 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. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
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 LocationUSA MA - Lexington
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Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
As a new employee what I like most about BD are the many learning and professional developmental opportunities for growth offered. It is good to know that there are so many resources to choose from.
Since joining BD, I really have liked the people I work with on a daily basis and the collaboration towards common goals.
Senior Program Manager
BD is full of passionate, loyal, and driven people that have a common goal of advancing healthcare without sacrificing quality or service.