Senior Quality Engineer

Summary - Main Purpose of the Position

As directed by the Quality Manager, the Sr. 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 unit policies, while meeting all design control and other regulatory requirements.

Responsibilities:

1. All responsibilities and duties specified within the Sr. QE job description

2. Applies consistent application of technical principles, theories, concepts and quality sciences / tools.

3. Applies strong problem-solving skills.

4. Makes measurable improvements to BD processes and procedures.

5. Ensures that all design control and production / process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements.

6. Is a team member representing Quality on new product development and sustaining engineering projects.

7. Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.

8. Assists with supplier and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and Good manufacturing Practices.

9. Writes and leads risk management activities including risk management reports and risk analysis.

Position-Specific Overview: Position specific responsibilities include support of the following, however are not limited to:

• Design Control
• Design Input
• Design Output
• Design Verification plans, protocols, and reports
• Design Reviews
• Design Validation
• Design History File support
• Change control
• Assessment of Change Request (ACR) Responses
• Risk Management
• Process Validations
• Identification of CTQ's
• Unit Quality Independent Reviewer During Design Reviews
• Handling of deviations and non-conformances
• Test method validations
• Post Market Surveillance
• Proper Use of Statistics (Sampling Plans)
• Liaise with Manufacturing Plants
• Provide functional support to cross-functional teams
• Internal and external audits

Scope of Responsibility:

Strategic Orientation:

• Contributes to the completion of specific programs and projects.
• Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and lower level project developers.
• Prepares/Revises policies/procedures.

Sphere of Influence:

• Works under general direction.
• Independently determines and develops approach to solutions.
• May provide guidance and work direction to other team members
• Designs and performs development working independently within defined parameters with minimal supervision required

Education/Experience:

• Requires a minimum of a Bachelors Degree in Science or Engineering; Biology or Chemistry preferred
• A minimum of 5 years relevant Quality experience
• Experience with statistics
• Class II / III medical device experience (preferred).
• Knowledge of six sigma methodology preferred. Knowledge of design control principles.
• Ability to support internal / external Quality Systems audit.
• Certified Quality Engineer (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?

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.

Required Skills

Optional Skills

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Primary Work Location

USA CA - San Diego (BDB)

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.

Salary Range Information
$99,000.00 - $163,300.00 USD Annual