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Sr Design Quality Engineer – Software
| Company | Becton Dickinson |
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| Location | San Diego, CA, USA |
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| Salary | $99000 – $163300 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Senior |
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Requirements
- Demonstrates strong knowledge of quality engineering policies, principles and best practices
- Understanding of regulatory and international standards requirements including 21 CFR 820, ISO 13485, ISO 14971 and IEC 62304 to support quality engineering activities
- Applies comprehensive knowledge of software quality concepts within the software development lifecycle
- Identify risks and proactively work with the program team to document risks and help to develop and ensure mitigation plans are in place
- Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc…)
- Applies knowledge and skills to a wide range of situations
- Qualified candidates will have a bachelor’s degree in a relevant degree field (engineering)
- Minimum 3 years’ experience with emphasis on R&D development, Quality Engineering and Design Controls
Responsibilities
- 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
- Actively reviews design artifacts to ensure compliance with QMS and good documentation practices prior to final approval
- Drive continuous improvements in QMS activities as it relates to software development lifecycle including post market through facilitating, leading, and collaborating with cross functional teams
- Work closely with program managers to ensure design deliverables are met and products can be commercially released in defined markets
- Identify gaps & improvement opportunities to ensure effective verification and validation of design specifications and requirements
- Active participant in the development of product requirement, product system hazard analysis and design reviews
- Works collaboratively to drive root cause analysis of failures, CAPA and use structured problem solving for product development and manufacturing issues
- Support internal and external audit activities as it pertains to software quality processes
- Ensure product technical files and Design History Files are complete and auditable.
Preferred Qualifications
- Software development experience within a regulated environment
- Strong background in software development methodologies
- Prior experience with supporting external audits with FDA, BSI, TUV etc
- Experience working in an iterative development environment like Scaled Agile Framework (SAFe) esp SAFe Certifications
- Thorough understanding of the risk management and quality by design
- ASQ Certified Software Quality Engineering Certification (CSQE) or equivalent
- Attentiveness to details with strong organizational skills
- Ability to work proactively and independently
- Ability to manage multiple priorities and be 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
