Staff Quality Engineer

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Location :
Carmel Valley, California

Expiry Date :
Sun, 25 Apr 2021 23:59:59 GMT

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SunIRef:Manu Job Description Summary Job Description Job Title: Staff Quality Engineer The Staff Quality Engineer is a key member of the New Products Development Team and is responsible for QA-related R & D activities from research through product launch. This position ensures that quality engineering principles are applied to new product development and sustaining engineering projects. Duties include: Responsible for being the core team quality representative for design control projects – new product development as well as sustaining efforts. Manage all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory and compliance support. Provide clarification and guidance to teams on overall quality system with emphasis in design controls. Work closely with Program Managers to ensure design deliverables are met and can be released to limited commercial and/or general release. Works together with Quality Engineers to ensure effective verification of design specifications and requirements. Monitors and ensures compliance with company policies and procedures (e.g. compliance with FDA, BSI, CSA, etc.). Identifies areas requiring quality improvement and initiates and follows through plans of action necessary for implementation. Active participant in the development of product requirement, product system hazard analysis and design reviews. Proactively engage partners to drive consensus and resolve issues in a timely fashion. Provide statistical support and expertise and analytical problem solving for product development and manufacturing Ensure product technical files and Design History Files are complete and auditable. Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross functional teams Job Family Summary Quality Engineering is responsible for product and service quality evaluation and control. Works cross-functionally in the development and/or maintenance of products or services. The Engineer is involved in resolving the equipment and process-related production issues, activities including equipment, process, materials and method validation as well as statistical analysis and metrics to analyze those systems and processes being measured. What is expected of you for success in your role Demonstrates strong knowledge of quality engineering policies, principles and best practices Understanding of regulatory and international standards requirements including 21 CFR 210, 211, ISO 13485, ISO 14971 to support work with little or no supervision Applies comprehensive knowledge of software quality concepts within the software development lifecycle Knowledge of hardware and firmware development processes Represents Quality organization on cross-functional product development Core Team(s) Identify risks and proactively work with the program team to document risks and help to develop and ensure mitigation plans are in place Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.) Applies knowledge and skills to a wide range of standard and non-standard situations Works independently with minimal guidance Usually determines own work priorities Acts as a resource for colleagues with less experience Qualifications: Qualified candidates will have a Bachelor’s degree in a relevant degree field (engineering) and minimum 8 years’ experience with emphasis on R & D development, Quality Engineering and Design Control Experience with Software and hardware development experience within a regulated environment is preferred. Strong background in software and hardware is preferred Thorough understanding of the risk management and quality by design is preferred Attentiveness to details with strong organizational skills Ability to work proactively and independently Ability to multi-task and efficient in time management Excellent verbal communication and interpersonal skills with the ability to work in a team environment Proficiency in Excel, Word, and other desktop/general business systems Quality Engineering Certification (ASQ) or equivalent (preferred) Why join us? A career at BD means that you are part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here you can fulfill your life’s purpose through the work that you 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. 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. #LI-PRO Primary Work Location USA CA – San Diego TC Bldg C & D Additional Locations Work Shift