BD is looking to hire a Staff Quality Engineer to ensure that design controls and risk management principles are applied to new product development and sustaining engineering projects for their Pyxis® medication technologies, aiming to prevent medication errors, free up caregiver time, increase medication availability predictability, and reduce inefficiencies in the med use process.
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 work with little or no supervision
- 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…)
- Software development experience within a regulated environment
- Strong background in software development methodologies
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
- Ensures effective verification and validation of design specifications and requirements.
- Reviews and ensures complete and comprehensive traceability of related design artifacts.
- Active participant in the development of product requirement, product system hazard analysis and design reviews.
Other
- Minimum 8 years’ experience with emphasis on R&D development, Quality Engineering and Design Controls
- Qualified candidates will have a Bachelor’s degree in a relevant degree field (engineering)
- 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
