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BD (Becton, Dickinson and Company) Staff Quality Engineer in San Diego, California

Job Description Summary

Job Description

Position Summary:

The Staff Quality Engineer supports medical devices with complex electro-mechanical systems. The associate is responsible for combining design control expertise, creative problem-solving approaches, and strong analytical skills to support new product development and product maintenance using quality engineering skills including but not limited to process validation, measurement system analysis, root cause analysis and design verification. The associate independently applies expert insight, experience, knowledge and skill, as well as implements, determines and develops best practices and procedures, to support complex and unique quality-related engineering activities (including, but not limited to product development, verification and validation) and to solve multifaceted and critical quality issues that relate to the implementation, maintenance and support of new and existing products.

Drives exceptional product quality, safety, design and reliability through Product Development and Quality teams and into the product. Manages the compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standard requirements. Oversees the methods and procedures for inspecting, testing, and evaluation of the precision and accuracy of production processes and equipment. Performs report and production data analyses to identify trends and recommend updates or changes to quality standards and procedures. Upholds the company's quality standards and testing systems to reflect efficiency, reliability and performance. Reviews documentation that reports issues relating to the production process.

The position requires experience with product transfers and the ability to handle multiple projects. In addition, this position 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.

Responsibilities:

  • Must possess in depth knowledge of quality engineering principles including risk management, root cause investigation, process validation, test method validation, process capability, trend analysis, statistical analysis, and statistical process control

  • Develop and implement process controls for new products and for transfers to manufacturing

  • Plan, develop and validate robust test methods which ensure acceptability of products under test

  • Develop and implement statistical process controls and sampling plans

  • Write, review and approve validation protocols for new products, processes and equipment, ensuring systems, utilities and processes comply with regulatory standards

  • Conduct and document root cause investigations in a systematic manner; ensure identified causes and associated corrective actions will reduce or eliminate sources of non-conformance

  • Support internal and external audits

  • Maintain up-to-date knowledge of Quality Systems Regulations and other relevant quality principles, regulations and standards

  • Influences on component, assembly, and final product quality for R&D and production builds.

  • Actively participates in risk management, design for quality and manufacturing requirements, product verification/validation, project planning, and associated documentation

  • Evaluates product and process changes and reviews for qualification and validation requirements, as well as participates in change implementations

  • Reviews inspection criteria and ensures inspection results and documentation support the recommended disposition action

  • Issues corrective actions and drives root cause investigation and corrective action implementation based on quality system feedback

  • Conduct knowledge transfer activities by training quality assurance engineers and inspectors on process transfer.

  • Lead investigation and on-time closure of non-conformances, corrective & preventive action.

  • Evaluate process risks and ensures appropriate production and process controls are identified, qualified and implemented throughout the product manufacturing lifecycle.

  • Collaborates with SME on all process validation activities to ensure consistent, repeatable and effective processes are implemented during design/manufacturing transfer.

  • Develop statistical rationale for testing, validation sample size, duration, and number of runs.

  • Support the training of Engineer and operator during production process transfer.

  • Monitor production process.

  • Assist/conduct Failure Investigations and problem-solving sessions for non-conforming products

  • Consistent application of technical principles, theories, concepts and quality sciences / tools

  • Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.

  • Contributes to the completion of specific programs and projects

  • Independently determines and develops approach to solution

  • May provide guidance and work direction to other team members

  • Designs and performs development working independently within defined parameters with minimal supervision required

  • Liaise with Manufacturing Plants

  • Provide functional support to cross-functional teams

  • Define product control strategy

  • Ensure/ perform process validation activities

  • Develop/ perform qualification plans have been defined and completed

  • Provide support to internal, regulatory body and customer audits and associated corrective actions.

  • Develop systems, processes, and procedures related to project quality activities.

  • Supports continuous improvement of current products and practices to improve quality, customer experience, and worldwide market share.

  • Customer facing teams by providing technical support from a quality perspective.

  • Support drafting quality agreements/plans

  • Ability to handle multiple projects simultaneously in an unsupervised environment.

Qualifications:

Education & Experience:

Bachelor’s Degree in Engineering or other scientific discipline, with a minimum of 12 years relevant experience or a combination of equivalent education and experience.

Skills:

  • Thorough understanding of industry regulations/standards: ISO 13485, QSR, GMP, IEC 60601, EU MDR

  • Knowledge of design control principles.

  • Thorough understanding of statistical methods for Quality Assurance

  • Experience in Quality System, Validation, FMEA/Risk Management.

  • Knowledge and experience in manufacturing, project management and engineering.

  • Experienced in production process transfers

  • Six Sigma Methodology Green or Black belt preferred

  • Expert knowledge of Quality System Regulations required.

  • In-depth practical experience with process and product quality, statistical sampling and analysis, design of experiments (DOE) gage R&R, ANOVA and validation required.

  • Excellent communication and presentation skills.

  • Knowledge of Microsoft Office required; knowledge of statistical software, and experience with large enterprise resource planning (ERP) system required.

  • Superior planning and organizational skills required.

  • Must be self-motivated and have the ability to work with minimal supervision; must also be able to work as part of a team.

  • A demonstrated excellence of problem solving sills required.

  • Excellent problem solving and analytical skills

  • Must possess excellent oral and written communication skills

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.

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Primary Work LocationUSA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift

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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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