Job Information
BD (Becton, Dickinson and Company) Senior Quality Engineer (Instrument Plant) in Sparks, Maryland
Job Description Summary
The Senior Quality Engineer has responsibility for applying/interpreting the applicable Quality Systems, developing/implementing the Standard Operating Procedures and policy’s for an organization, such as Quality control, or a manufacturing plant. Develops and maintains schedules and timelines. Ensures the documentation process remains compliant.
The role provides guidance for the various elements of the Quality System, for example, to ensure process control, consistent supplier qualification practices and identifies/recommends opportunities for continuous improvement internal/external). Applies the appropriate statistical tools to analyze data, identify root cause and corrective actions for effective problem resolution of moderate to difficult scope and complexity. May support both internal and external audits by assuming the Lead Auditor role.
Responsibilities include monitoring and trending quality indicators for purchased materials as well as manufactured and distributed components/products. Assesses Critical To Quality (CTQ) parameters and
risk assessment variables as part of the decision making processes to support predictable product design and flow. Initiates CAPAs and may lead the investigation/corrective action process.
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.
Responsible for all aspects (product and process) related to the quality of the Instrument Plant for the designated product line(s). This includes manufacturability of products at the Instrument Plant, supplier manufacturing, customer requirements and complaints. The Senior Quality Engineer will be responsible for developing and maintaining the Design History File, product and supplier quality. Develops, modifies, applies and maintains quality standards and protocols.
General Responsibilities:
Maintain FDA (Food & Drug Administration) and ISO (International Organization for Standardization) regulatory requirements.
Key elements of focus are (but not limited to) product design for manufacturability, customer complaints, assembly and test, inspection and validation throughout the development process.
Generate process/product quality information in the form of Critical to Quality indices and share with project team/operations recommendations and solutions to emerging issues.
Improve key quality metrics (Fist Pass Acceptance, Quality Notifications and Complaint data).
Develop department programs / processes on continuous improvement and standardization across the BD Diagnostic Systems.
Supports the coordinated integration of new products into Manufacturing / Operations.
Ensures BD Diagnostic Systems divisional, departmental policies, procedures, practices and facilities are in compliance with all applicable regulatory policies.
Develop Design / Device History Files and maintain in a manner consistent with FDA (Food and Drug Administration) requirements
Understanding of Quality Systems and procedures
Other emerging responsibilities as identified and assigned.
Minimum Requirement:
- Degree level qualification; or equivalent combination of education and 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.
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.
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Primary Work Location
USA MD - Sparks - 7 Loveton Circle
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.