This position will act as the quality representative regarding quality interests and concerns on manufacturing project teams as well as getting involved in a variety of projects which may include, resolving quality problems, improving areas of high-quality costs, assisting suppliers and subcontractors in meeting BD's quality needs.
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 o ur 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:
Design and conduct Quality Engineering studies to determine causes of quality non-conformances, initiate changes in process, tooling, product design, etc. to correct them.
Provide technical support to resolve quality problems in manufacturing or with suppliers as warranted.
May perform qualification studies for new suppliers, components, and inspection test equipment.
Plan and execute validations (IQ/OQ/PQ) and qualification studies as needed for new/existing equipment (inspection & process), software, components, etc.
Provide documented instructions for performance of Q.C. Inspections, including Inspection plans, Test Procedures, and Quality Standards.
Evaluate customer's specifications for BD's ability to comply.
Support other manufacturing and business goals. Contribute ideas to these programs and work on implementation. Serve on committees, teams, task forces as assigned.
Conduct other Quality Projects as assigned by the Quality Engineering Manager.
Exercise control over the quality of conformance of the products generated in areas assigned.
Completes Material Review Notice (MRN). This includes maintaining database and reporting to management.
Reviews DHR documentation for compliance and release of components and finished product.
Education and/ or Experience Required:
Bachelor's Degree in Engineering field or 2 to 4 years QE Experience with a Bachelor's Degree
With Bachelor's Degree in Engineering, 1-3 years experience working in Quality Engineering (preferred)
Experience in CAPA and root cause analysis
Experience in validation and process controls (preferred)
FDA regulation experience (preferred)
Experience with ISO 13485 and 21CFR PART820 (preferred)
Applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment Visa at this time.
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.
