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 To apply, submit a resume to https://bdx.wd1.myworkdayjobs.com/EXTERNAL_CAREER_SITE_USA, OR mail resume to Becton, Dickinson and Company, Attn: BDHR - DT, 3750 Torrey View Ct, San Diego, CA 92130, OR submit a resume to https://www.caljobs.ca.gov/vosnet/Default.aspx. Must reference Job Title & Job Code: R-556169. Required Skills Optional Skills Primary Work Location USA CA - San Diego Bldg A&B Additional Locations 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. 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