Job Details
Level: Experienced
Job Location: Rigaku Analytical Devices, Inc. - Wilmington, MA
Position Type: Full Time
Travel Percentage: Negligible (Up to 10%)
Job Shift: Day
Job Category: QA - Quality Control
Description
Rigaku is looking for a senior software QA engineer responsible for leading Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new development initiatives. This includes ensuring that the software development process is compliant with applicable standards & regulations. This role will interface with other departments (e.g. Sr. Management, Operations, Service, Product Development and Engineering) as well as other external parties on issues related to product development, launched product support, and software used for automation of the quality system. The ability to effectively communicate software and design and development regulations, optimize the development process, and ensure ambiguities and conflicting requirements are resolved are critical to the success of the position.
Duties include the following:
- As a quality representative on the project's core team or extended team, take responsibility of ensuring that all design control activities including design inputs, design, and development planning, design reviews, design verification and validation & test method validation.
- Review and approve design control and product documentation.
- Ensure product safety by driving risk management activities including authoring risk management plans.
- Ensure that software deliverables including software requirement specifications, software development plans, software architecture documents, and software verification and validation plans are compliant to software development lifecycle process procedures.
- Act as a member of Issue Review Team meetings to ensure that software bugs are evaluated and addressed appropriately.
- Support the successful transfer of products to manufacturing by ensuring the adequacy of process validation, design transfer plans, quality plans and supplier documentation.
- May plan and execute internal audits against applicable quality system standards, regulations and internal procedures.
- Administration level control of Atlassian/Jira tools.
Qualifications
Requirements:
- BS or higher degree in engineering, or similar.
- 5 years minimum Quality experience, including experience in leading design control and risk management activities.
- Familiar with Software Source Control packages & Software Development and Collaboration tools. Specifically the Atlassian/Jira tools.
- Excellent verbal, and written communication skills.
- A highly motivated fast learner who can work independently with minimal guidance.
The ideal candidate also should:
- Have experience in GUI for portable design and Human Factors Engineering for Analytical Instrumentation.
- Linux kernel module development.
- Web development using the scripting language PHP, JavaScript and React.
- Experience with the design and optimization of databases and networking.
- Demonstrated ability to successfully complete complex R&D technology projects.