Staff Supplier Quality Engineer

Company: Becton Dickinson
Location: San Diego
Posted on: September 23, 2022

Job Description:

Responsibilities Job Description SummaryReporting into the Supplier Quality organization, this position supports all efforts in developing and management for all San Diego and Tijuana suppliers. Primary responsibility for this position includes ensuring suppliers are compliant with BD standards and applicable US & global regulatory requirements as well as ensuring supplier has capacity and capability to meet BD demand. This position is accountable to provide leadership, development and coaching to suppliers as well as internal Supplier Quality Engineers. This position partners with internal stakeholders to ensure compliance to product, customer, and regulatory expectations. Key areas of focus within supplier management are leading supplier & process qualifications, leading issue/defect resolution, managing performance monitoring/reporting, compliance to appropriate standards, and streamlining/developing processes. Key areas of support provided to team members include management of non-conformances, risk management/ communication, defect resolution, process capability/process improvement, and quality assurance general support. Job Description Be part of something bigger BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. Essential Roles Adheres to environmental policy, procedures, and supports department environmental objective. Leads supplier qualification/approval process by assessing supplier QMS as well as manufacturing and technology capabilities through onsite and virtual audit activities Leads design, development, and manufacturing operations toward resolution of supplier quality problems as well as the implementation of corrections and corrective actions Works with suppliers to develop, establish and maintain robust/rigorous measurement methodologies. Provides oversight of junior SQE staff Partners with suppliers to establish and maintain controlled manufacturing processes Ability to collaborate externally with suppliers as well as internally with Quality, Operations, Supply Chain, Procurement and Engineering. Provides oversight and mentors root cause analysis and corrective actions for supplier quality issues (SCARs) Leads supplier validation activities using Advanced Product Quality Planning (APQP) Leads supplier Production Part Approval Process (PPAP) activities Leads resolution to issues based on the reporting of supplier quality trends, performance, and other information to leadership Travel up to 25% may be required Creates, owns, and subsequently implements assigned Quality Plans Leads assigned Corrective Action and Preventive Action (CAPA) projects and implements relative action items. Mentors junior engineers Leads the use of techniques for continuous improvement such as Lean, Six-Sigma, Poka-Yoke (Error Proofing), Measurement System Analysis and FMEA (Failure Mode and Effects Analysis) Partners with suppliers to establish and maintain controlled manufacturing processes Develops and implements strategies for driving process and product improvement initiatives at suppliers. Develop, review and approve engineering/test and supplier documentation and provide input to assure that appropriate quality and operational requirements are addressed. Leads, develops and supports the supplier development process, procedures and work instructions. Develops and deploys SPC initiatives at suppliers based on BD needs. Develops Supplier Quality engineers. Evaluate and make recommendations on critical supplier selections, including leading on-site audits, evaluating prototypes, and reviewing and approving of supplier corrective actions. Evaluate the precision and accuracy of production and processing equipment and testing, measurement, and analytical facilities at suppliers. Interacts with product design and development personnel and Supplier personnel to ensure that processes and designs are compatible. Recommends equipment and process modifications for Suppliers to meet quality standards and improve process capability & manufacturing techniques. Evaluates and provides feedback on financial impacts of supplier quality process controls and inspections. Attend appropriate supplier, customer, business or program meetings. Delegates and oversees the work of assigned analyst, technician, and engineering staff Other duties and responsibilities as assigned. Lead supplier qualification and process audits of suppliers to ensure good manufacturing practices (GMP) and quality standards are met. Minimum Experience: Bachelor's degree in an engineering discipline is required. Master's or Doctorate Degree preferred A minimum of 10 year's total experience in a Quality engineering role is required. A minimum of 5 years in a Supplier Quality engineering role required Prior experience within a regulated industry (e.g., medical device, pharma, Automotive, Aerospace) is required ISO 13485 Lead Auditor certification is required CAPA experience- Candidate to have owned and completed multiple CAPAs successfully Design Controls- Candidate to have in-depth knowledge of Design Controls throughout product lifecycle Demonstrated knowledge and ability to train others in the Quality Engineering body of knowledge is required Good communication and strong writing skills are required Experience with one of these commodities required: PCB, PCBA, or electro-mechanical ASQ certifications required (CQE, CRE, CSQE, Six Sigma, CMDA, CQA) Demonstrated knowledge and ability to train others of DMAIC\Six Sigma and problem-solving methodologies Candidate must be able to work autonomously and independently in addition to providing guidance to Junior engineers Working knowledge and experience on at least 2 of these standards required: 21CFR part 820 (QSR), ISO13485, ISO/TR 24971:2020, IEC 60601-1, IEC 62304, IEC 623666-1, ISO 10993-1 Production or engineering management preferred International / multi-cultural experience preferred Knowledge, Skills, and Abilities Requirements Strong negotiating, influence, and leadership abilities Strong communication skills. Ability to communicate clearly and efficiently during difficult situations Ability to work in a team environment and work through others Strong analytical & problem-solving skills. Ability to lead teams through problem solving process. Ability to build and maintain a team and to work in a matrix organization Ability to define a project and direct teams through execution Action oriented when facing issue, change and uncertainty Use data to drive decision making process Leadership skills 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 empowers you to bring your authentic self to work. Here our associates can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components - is designed to support the varying needs of our diverse and global associates. To learn more about BD visit https://jobs.bd.com/ 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. PDN Primary Work LocationUSA CA - San Diego TC Bldg C&D Additional Locations Work Shift Apply Save Job PDN-970402d9-cd77-4b92-9ca1-cb9ca4859ef5

Keywords: Becton Dickinson, San Diego , Staff Supplier Quality Engineer, Engineering , San Diego, California