Sr. Quality Engineer, Software

Regulatory Jobs; San Diego (CA); On-site; USD 137,000 - 169,000; Full time

Benefits offered by this job

Total Rewards program

Competitive compensation

Job summary

BD is seeking a core team quality representative for design control projects, focusing on new product development and sustaining efforts in San Diego. You will manage quality planning, verification/validation, risk management, and regulatory support, ensuring traceability and conformance to QMS, working with cross-functional teams to drive root cause analysis and continuous improvement.

Bachelor’s degree in Engineering with 3 years of experience; familiarity with 21 CFR 820, ISO 13485, ISO

Qualifications

• Bachelor’s degree in Engineering or related field with 3 years’ experience.
• Experience with quality engineering policies, regulatory standards (21 CFR 820, ISO 13485, ISO 14971, IEC 62304).
• Software V&V experience; software development in regulated environments; familiarity with SAFe.

Responsibilities

• Manage all quality aspects of the design control process.
• Provide guidance on quality system and design controls.
• Review design artifacts for compliance with QMS and good documentation practices.
• Collaborate with program managers to ensure deliverables meet release timelines.
• Drive root cause analysis and structured problem solving for development and manufacturing issues.
• Ensure product technical files and Design History Files are complete and auditable.
• Lead continuous improvement across cross-functional teams.

Skills

Quality engineering

Regulatory knowledge

Software V&V

SAFe

Root cause analysis

Education

Bachelor’s degree in Engineering or related field

Tools

QA tools

Regulatory standards

Job description

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

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.

Job Description Summary:

Core team quality representative for design control projects – new product development as well as sustaining efforts. Manage all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; and regulatory and compliance support. Provide clarification and guidance to teams on overall quality system with emphasis in design controls. Review design artifacts to ensure compliance with QMS and good documentation practices prior to final approval. Work closely with program managers to ensure design deliverables are met and products can be commercially released in defined markets. Ensure effective verification and validation of design specifications and requirements. Review and ensure complete and comprehensive traceability of related design artifacts. Active participant in the development of product requirements, product system hazard analysis and design reviews. Work collaboratively to drive root cause analysis of failures and structured problem solving for product development and manufacturing issues. Ensure product technical files and Design History Files are complete and auditable. Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross functional teams.

Qualifications

Bachelor’s degree in Engineering (any), Information Technology, Information Systems, Computer Science or related field of study and three (3) years of experience in the job offered or related occupation in which the required experience was gained. Must have demonstrated experience with: Quality engineering policies, principles and best practices; regulatory and international standards requirements (21 CFR 820, ISO 13485, ISO 14971 and IEC 62304); Quality Engineering tools (Sampling Plans, Root Cause Analysis and Statistics); Corrective and Preventive Actions; Risk Management for Medical and Non-Medical Devices; Audits/Inspections; Software Verification and Validation; Software development within a regulated environment; software development methodologies; and Scaled Agile Framework [SAFe].

Salary offered for the position is: $137,041.61 - $168,800.00/year.

Primary Work Location

3750 Torrey View Ct., San Diego, CA 92130

Additional Locations

N/A

Work Shift

Not Specified

• 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.
• You can learn more on our career site under "Our Commitment to You".

• Our salary or hourly rate ranges reward associates fairly and competitively.
• We regularly review these ranges and factors, such as location, contribute to the range displayed.

• Our pay is based on the role and the necessary skills and education to perform it successfully.
• The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location.
• Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$105,500.00 - $168,800.00

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 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.

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.

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 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.

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.

Primary Work Location

USA CA - San Diego Bldg A&B