We have an immediate opening for a highly motivated, results-focused professional to join our team, and are adding to our staff as a Sr. Quality Engineer. The Quality Engineer's primary responsibilities are to support new product development activities, maintain compliance to company procedures and external standards, manage design history files, create verification and validation documentation, participate in risk analysis activities, collaborate on product development deliverable documentation, conduct failure\problem investigations, identify system issues, summarize findings and prepare reports for key quality metrics.
The Sr. Software 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 prime quality representative for design control projects – new product development as well as sustaining efforts.
- Responsible for review and/or approval of design history file documentation in support of design controls.
- 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 SW 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.).
- Reviews and approves Change Orders and/or Electronic Release Authorizations for new releases or design enhancements.
- 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.
- Work closely with Product Management to ensure effective validation of user needs.
- Ensure product technical files and Design History Files are complete and auditable.
- Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross function 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.
What is expected of you for success in your role
- Demonstrates intermediate knowledge of quality engineering policies, principles and best practices
- Demonstrates intermediate knowledge of FDA/ISO requirements
- Applies intermediate understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with little or no supervision
- Applies comprehensive knowledge of software quality concepts within the software development life-cycle
- Comprehensive knowledge in software development life-cycle as well as test processes and methods
- Able to pull reports (queries), interpret trends and make recommendations for improvement to existing tools
- Uses comprehensive expertise to help improve and streamline the software quality or development process
- Represents Quality organization on cross-functional product development Core Team(s)
- Review complex test cases/scripts and interprets/analyzes results to report, communicate, and work through issues with testers and software engineers
- Considered expert in critical areas of the system and influences project test solutions
- Can apply comprehensive understanding of the inter-workings of the application code under test
- Participates in conducts code reviews and design reviews
- Applies software engineering knowledge to tasking (eg. code and detailed design reviews, low-level white box testing, 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
- Qualified candidates will have a Bachelor's degree in a relevant degree field (software engineering) and minimum 5 years' experience with emphasis on R&D development, Software Quality
- Engineering and Design Control
- Experience with software development experience within a regulated environment is desired.
- Strong background in software 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