Senior Quality Engineer



 We are the people who give possibilities purpose

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.



 Job Description

As directed by the Associate Director - Quality, the Senior Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance, and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and Business Unit policies while meeting all design control and other regulatory

requirements.

Responsibilities:

• Provides support/mentoring/coaching for application of technical principles, theories, concepts and quality, tools and systems. Develops technical solutions to complex problems which require the regular use of technical knowledge, experience, ingenuity, and creativity. List a core team member for complex design control / process control projects.  Can serve as a CAPA expert.
• Modifies methodologies and procedures, ensuring continuous improvement of desired outcomes. Supports quality system audits.
• Provides input to the management review process
• May perform other duties as required
• Scope of Responsibilities
• Develops advanced technological ideas and guides their development into a final product, process or business opportunity.
• Ensures the accurate and actionable recording of data for the making of decisions as well as to document development work
• Contributes to long-range business strategies, choosing disciplines and methods appropriate to the work content and context
• Outputs contribute to reduced cycle times, improved effectiveness and furthering the achievement of goals critical to company objectives
• Position-Specific Overview
• Position specific responsibilities include support of the following, however, are not limited to:
• Design Control
• EU MDD/MDRl
• Change control
• Risk Management
• Process Validation
• Identification of CTQ's
• Handling of deviations and non-conformances
• Test method validations
• Supplier qualification
• Post Market Surveillance
• CAPA – Root cause investigation and implementation of corrective / preventive actions
• Proper Use of Statistics (Sampling Plans)
• Advise on Regulations and standards
• Liaise with Manufacturing Plants
• Provide functional support to cross-functional teams
• Support Internal and external audits
• Sphere of Influence
• Work is performed without appreciable direction.
• Assignments are often self-initiated.  Determine and pursue courses of action necessary to obtain desired results.
• Plans and participates in disciplines strategically relevant to the business and/or functions
• Provides advice and mentors junior Associates
• Participates in, and may provide  leadership for, multi-disciplinary projects
• Considered Site / functional level Subject Matter Expert.
• May be assigned as site / functional extended team member

Qualifications

• Bachelor’s Degree
• A minimum of 7 years of relevant experience or a combination of equivalent education and relevant experience
• Minimum 5 years of experience supporting design assurance for medical devices
• Extensive knowledge of applicable regulatory, Corporate and/or Unit requirements. Applicable Regulatory and Industry standards (21-CFR-820, ISO 13485, MDD, MDR, ISO 14971,ISO 10993, etc.)Quality Engineering tools, Statistics, Problem Solving, strong Interpersonal Skills, Leadership, all forms of Communication
• ASQ Certificate(s) desirable (but not required)
• Design for Six Sigma preferred
• At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
• 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?
• 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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
• We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
• To learn more about BD visit https://bd.com/careers .
• Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.
• Required Skills
• Optional Skills.
• Primary Work Location
• USA CA – Brea
• Additional Locations
• USA CA - San Diego Bldg A&B
• Work Shift
• 

 At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs.