Sr. Quality Engineer

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Location :
San Diego, California

Expiry Date :
Mon, 08 Mar 2021 23:59:59 GMT

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Job Description Summary Job Description The Sr. Quality Engineer is directly responsible to the Quality Manager for the continued development, improvement and implementation of the Quality Systems. This position provides quality guidance, product resolution decisions and statistical problem-solving techniques to New Product Development and project teams for process improvement and continuous improvement activities. The Senior QE uses the Quality Systems to ensure overall compliance and has the knowledge necessary to apply the appropriate statistical and analytical tools. The Senior QE works with variable enterprise systems/Corporate directives to support new and/or current product lines and processes. The Senior QE will assist the Quality Manager in assuring the facility complies with ISO 13485, 21CFR Part 820, and other applicable external regulations as well as internal site regulations/procedures through supporting the IDS cGMP program. Job Responsibilities: Typical assignments may include: performing tasks, of moderate complexity, within planned schedules and timelines, supporting audits, actively leading or participating on project teams, ensuring documentation compliance on plant specific documents and handling customer complaint investigation/resolution. Frequent interaction with other functional areas such as R & D, Manufacturing, Regulatory and Marketing etc. is routine. May take the lead in root cause investigations for issues of moderate complexity. The Senior QE carries out Design Control activities such as Design History File audits and maintenance. The Senior QE assists in maintaining and monitoring the customer complaint system by receiving, evaluating and responding to every customer issue through Product Incident Reports. Chronic quality problems resulting in trends of nonconforming materials or components are investigated as part of customer complaints. Works closely with Manufacturing, Engineering, and R & D for identifying the root causes and developing corrective action and preventative action plans in the event of validated complaints. These may include revisions to ITs and SOPs through Change Control based on the results from complaint analysis. Driver of Continuous Improvement by leading and directing completion of significant plant projects according to specified time lines. – Provides advice, updates, and troubleshooting to quality product and processes using technical and enterprise knowledge independently and in team environments. Consults more Senior Quality personnel for complex issues. – Supports implementation of corrective actions and improvements by coordinating SAP data/documentation for specific Quality Notifications. – Provides prompt responses to Production and inquiries from both internal and external customers by acting as consultant. These may be in the form of Stability Requests, material specific questions/comparisons or procedural explanations. – Performs all duties in accordance with all applicable IDS Quality, Safety and Operating Procedures. – May work closely with Sales and Marketing to establish strong working relationships with key customers. – Actively supports appropriate training and development for associates, where assigned. – Fosters communication and cooperation within and across manufacturing sub-teams. – Supports internal and External audits. – Supports other local Quality personnel such as Validation by consulting on current projects and reviewing completed Validations. – Develops and maintains efficient methods for regularly reporting to management the current status of product quality with respect to Quality objectives and goals, and provides plant quality metrics as required to generate quality system improvements. – May perform other duties as required. Minimum Qualifications: Education and Experience: – Bachelor’s Degree in Biological Sciences or related field required. MS in Biological Sciences or related field preferred. – Minimum of 5 years’ experience in product development, research & development, quality engineering, project management, manufacturing and continuous improvement environments. – Microbiology & statistical analysis (Minitab) experience strongly preferred. – Six Sigma Certification is a plus. Knowledge and Skills: – Must demonstrate a working understanding of the pertinent Quality Systems/Regulations (i.e. Quality System Regulation, ISO, FDA) – Proven ability to develop solutions to a variety of problems of moderate scope and complexity. Accesses policies and procedures for guidance. – Capable of using Microsoft Word/Excel/Access. – Working knowledge of statistical methods as well as statistical application software such as Minitab. – Effective verbal and written communication skills. – The ability to work in teams and independently with minimal supervision to obtain results as required. – Must be self-motivated/directed, organized, detail oriented and have ability to multi-task projects. – Ability to work with all levels of personnel, from senior leadership to production staff to external customers. 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. #LI-TECH Primary Work LocationUSA CA – San Diego (Diagnostic Sys.) Additional Locations Work Shift