Staff Quality Engineer I

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Location :
San Diego, California

Expiry Date :
Mon, 05 Apr 2021 23:59:59 GMT

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Description :
Job Description Summary Job Description The statements below are intended to describe the general nature and level of work being performed by associates assigned to this job. This job description is not intended to be an exhaustive list of all responsibilities, duties, and skills required of associates so classified. JOB SUMMARY : – Manage the Contract Manufacturer to deliver products that are in compliance to manufacturing process and participation in new product process development. – Manage and provide guidance to Contract Manufacturer in producing consistent product quality meeting product specification. – Conduct Quality Management System Training and Audits to ensure conformance to Standard. – Initiate risk assessment, review and approve Process Verification and Validation Plan to ensure consistent Product Quality before change. – Support local and global Supplier Quality Program for Point of Care. DUTIES AND RESPONSIBILITIES : – Coordinate and integrate Quality and Manufacturing activities across BD sites to ensure process alignment for Veritor Product. – Conduct Quality Training to dry Continuous Improvement – Conduct Supplier Audit including assessment of new or potential supplier – Conduct Contract Manufacturers Supplier Audit and access effectiveness to mitigation plan in resolving non-compliances. – Participate in process development and VnV (Verification and Validation) Plan for new product inclusive of Risk Hazard Analysis training to Process Development Team. – Responsible for communicating and working with Suppliers in regards to Quality issues. – Collects, interprets and analyzes data and presents to others either orally or in writing. – Participate on Supplier Improvement project teams. – Responsible for SAP Transactions as required. – Responsible for revising and creating Buy Specifications. – Acts independently, consults with supervisor on unusual situations. – Work closely with Purchasing on Supplier related activity. – Travel required for as needed. MINIMUM QUALIFICATIONS : – Must have highly developed computer skills in Word, Excel and PowerPoint. – Working knowledgeable of ISO 13485 and 21 CFR Part 820. – Problem solving abilities a plus. Able to perform root cause analysis. – Six Sigma / Lean and Statistics background a plus – Must be organized and be able to implement programs and projects. – Ability to communicate and work with all levels of Plant, Division and Supplier Personnel. – Willing to travel up to 50% dependent upon business need. KNOWLEDGE AND SKILLS: – Experience and expertise with quality data analysis and statistics (SPC, Pareto charts, etc.) – Strong interpersonal skills, demonstrated capability of working on multiple projects at one time. – Strong oral and written communication skills. – Strong problem solving skills. – Demonstrated project management skills. – Ability to lead without authority – Experience in transactional six-sigma will be an advantage EDUCATION AND EXPERIENCE: – Four year Bachelors degreeplus5-7 years of quality engineering experience required. Primary Work LocationUSA CA – San Diego (Diagnostic Sys.) Additional LocationsUSA MD – Sparks – 7 Loveton Circle Work Shift