Sr. Quality Engineer, Software

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

Job summary

BD, Becton, Dickinson and Company, is a global medical technology leader turning health care into better outcomes. This role serves as core team quality representative for design control projects, managing quality planning, verification and validation, risk management and regulatory support to enable product releases in defined markets.

You will review design artifacts for compliance, drive root-cause analysis, ensure traceability of DHFs, and collaborate with cross-functional teams to improve

Qualifications

• Bachelor’s degree in Engineering or related field and 3 years in quality-related roles.
• Experience with quality engineering policies, regulatory standards and risk management.
• Knowledge of software verification, validation and SAFe/agile practices.

Responsibilities

• Manage all quality aspects of the design control process including planning, V&V, risk management and regulatory support.
• Review design artifacts for compliance with QMS and good documentation practices.
• Collaborate with program managers to ensure traceability and timely product release.
• Drive root cause analysis of failures and continuous improvement across development and manufacturing.
• Maintain complete and auditable Design History Files and support cross-functional teams.

Skills

Quality engineering policies

Regulatory standards knowledge

Root cause analysis

Risk management

Software verification & validation

SAFe / Agile

Statistics / sampling

Education

Bachelor’s degree in Engineering or related field

Tools

Sampling Plans

Root Cause Analysis tools

Statistics software

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

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.

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.

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.

Why Join Us?

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.

Salary Range Information $105,500.00 - $168,800.00

We are the #MakersofPossible Working together, we make products that patients, families and their healthcare professionals rely on. We do this because we are committed to advancing the world of health. But it takes the imagination and passion of all of us at BD, from manufacturing to marketing, to look at the impossible and find solutions that turn dreams into possibilities with real-life health benefits for people today, tomorrow and beyond. We make this happen, together. We are the makers of possible.

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.