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.
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
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.
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.
Cost Center Specific:
Support new product development teams and being able to represent quality in cross-functional team settings.
Perform trend analysis, FMEA (Failure Mode and Effect Analysis) and six sigma tools.
Requirements:
Education
Bachelor's degree (Engineering, Biological Sciences, Chemistry, and/or Computer Science or other related field.)
Experience:
a) Minimum of 3 years of Quality Operations or Regulatory experience in the medical device environment or,
b) 5 years in manufacturing environment or,
c) Master's with 3 years of experience.
Experience and understanding of electro-mechanical instrumented systems. Professional certifications such as Certified Quality Auditor/Certified Quality Engineer, Six Sigma preferred.
Ability and skill to effectively manage multiple tasks and drive execution of change management plans
Ability and skill to lead or manage process control, supplier quality and continuous improvement projects using statistical technique/tools such as: Statistical sampling, SPC
Six sigma, additionally root cause analysis and project management techniques are routinely employed
Ability to effectively write communications that ensures clarity, accuracy and consideration of the audience
Ability to speak with clarity and express points of view in a variety of settings; one-on-one interactions, group meetings, and formal presentations
Ability to listen to others; including associates, managers, peers and customers when making decisions and solving problems
Ability and skill to analyze data using systematic analytical tools such as Six Sigma, root cause analysis, failure analysis and risk assessment to gather critical information that has moderate to difficult complexity
Ability to drive for results and effectively work through conflicts in working teams by facilitating conflict resolution
Sound workable knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 9000:2000 and ISO 13485:2003
Professional certification preferred. Six Sigma, ASQ, AAMI
Experienced in Microsoft Office suite skills. Basic mini tab and/or related analytical software programs
Preferred: Certification such as ASQ-CQA/CQE, AAMI, Six Sigma or a Company certification such as Green Belt, Black Belt, IGQA auditor.
Knowledgeable in specific automated systems as noted and engaged in new product introductions as a possible Core Team member representing the Quality function.
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.
Primary Work Location
USA MD - Sparks - 7 Loveton Circle
Additional Locations
Work Shift
At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You .
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.
