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Senior Quality Engineer

Company: BD
Location: Scotts Valley
Posted on: November 22, 2021

Job Description:

Job Description Summary Job Description As a Senior Quality Engineer, you will be accountable as Quality Assurance representative to support reagent product and process sustaining and/or product development activities through the application of Quality engineering skills for medical devices. Emphasis will be on process, equipment, software validations, working with teams to develop manufacturing processes and define their related tools, resolve validation strategy, and write, execute, and approve validations.For Sustaining Product, the Quality Engineer will understand, improve, and control operational processes to realize predictable product flow while satisfying established regulatory and BD standards of quality. The Engineer will handle projects and tasks, from product inception through product launch and maintenance. They will play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements. Activities include working independently or with a team to perform process validation, risk assessment and management, design control, CAPA, and supplier management. Engineer will give mentorship to current and new Quality procedures. Successful performance requires close work with quality management, operations, R&D, suppliers and/or BD associates to assure compliance with all BD quality policies, procedures, and practices. Primary Responsibilities and Duties Supports quality activities for the development, implementation, and ongoing support of IVD reagent products and their related processes

  • Products include, but are not limited to IVD liquid and dried antibody and system calibration products
  • Accurate process improvements, quality assurance and regulatory compliance
  • Provides critical quality engineering direction to projects with respect to generally accepted quality engineering tools/principles, such as design and process validation, measurement systems analysis, equipment, root cause analysis, FMEAs, risk mitigation, DOE/other process improvement tools, sampling and control plans.
  • Demonstrates proven understanding and application of regulatory, Corporate and/or Unit requirements.
  • Establishes a strong working relationship with all levels of operations to appropriately supervise and analyze in-process inspection, process control activity, and waste and reject rates, PM compliance, environmental control and customer complaint levels in order to take a lead role in identifying and detailing continuous improvement projects.
  • Leads and assures appropriate CAPA activities to accomplish internal/external objectives.
  • Design Control (Both New Product Development and Sustaining Processes as applicable)
  • CAPA -- Root cause investigation and implementation of corrective / preventive actions
  • Proper Use of Statistics (Study design, Sampling Plans, and Data Analysis)
  • Advise on Regulations
  • Provide functional support to multi-functional teams
  • Teach and assist associates in Quality system concepts and documentation
  • A minimum of 3 years validated experience in a quality related function and 1 year in a medical device or other FDA regulated environment , or a combination of higher equivalent education and proven experience. Assets:
    • Knowledge of process, test method, equipment, and software validation (IQ, OQ, PQ).
    • Certified Quality BioEngineer (preferred)
    • Certified Six Sigma Green Belt
    • Knowledge of applicable regulatory requirements including ISO13485, ISO14971, ISO9001, quality systems regulations (21 CFR: 820)
    • Knowledge of design control principles preferred.
    • Experience with Minitab or other statistical software, MS Excel, and MS Word preferred. Come work with Us! Why join us? A career at BD means being part of a team that values your perspectives 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 hardworking and committed to encouraging an inclusive, growth-centered, and exciting environment. Our Total Rewards program -- which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components -- is crafted to support the varying needs of our diverse and global associates. 401(k) matching contribution, Paid Time Off ! To learn more about BD visit 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. Primary Work Location USA CA - San Jose Additional Locations Work Shift

Keywords: BD, San Francisco , Senior Quality Engineer, Engineering , Scotts Valley, California

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