Job Description Summary: Assist with all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory and compliance support. Actively reviews design artifacts to ensure compliance with QMS and good documentation practices prior to final approval. Ensures effective verification and validation of design specifications and requirements. Complete traceability of related design artifacts. Support in the development of product requirement, 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. Qualifications: Master’s degree in Industrial, Mechanical or Manufacturing Engineering and three (3) years of experience in the job offered or related occupation in which the required experience was gained. Must also have demonstrated experience in the following: Regulatory and international standards requirements including 21 CFR 820, ISO 13485, ISO 14971 and IEC 62304 to support quality engineering activities; Application of Software Quality Concepts specifically ensuring compliance with Software Development LifeCycle (SDLC) per IEC 62304; Development and maintenance of multi-directional traceability matrices from user needs, product requirements to design specifications, risk controls, and design verification; Quality Engineering tools such as: Root Cause Analysis, Design of Experiments and Statistical Analysis); Quality Audit Management (Internal and External) - performing internal audits and representing the QMS during external notified body audits; Medical Device Defect review and tracking - Risk based defect triage and disposition aligning post-production issues with hazard analysis and clinical impact; Corrective and Preventive Action (CAPA); Engineering Design Change Management and DHF Management for Medical Devices; Safety-Critical Hazard Analysis and Risk Management; and Customer complaints, Medical Device Reporting (MDR) assessments, and post market non-conformance reporting. Salary offered for the position is: $131,817.00 - $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://www.caljobs.ca.gov/vosnet/Default.aspx, OR 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. Must reference Job Title & Job Code: R-550587. EOE. #DNPBD Primary Work LocationUSA CA - San Diego Bldg A&B 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