QA Engineer responsible for supporting testing activities of telephony software solutions at Saab, ensuring quality standards before deployment. Collaborating with development teams and influencing design decisions throughout product lifecycle.
About the role
- Quality Engineer managing quality standards and procedures for medical devices in a hybrid role. Working on process control, validation, and supplier collaboration in a leading company.
Responsibilities
- Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection.
- Design experiments to understand sources of variation affecting products and processes.
- Direct and collaborate with supplier representatives on quality problems and ensure corrective action implementation (CAPA, SCAR).
- Work with Regulatory Groups and Suppliers to produce 510K submissions, letters to file, etc.
- Perform quality reviews of design documentation for compliance with stated requirements.
Requirements
- Typically requires a Bachelor’s degree in Engineering, Science, Math or other related technical field.
- At least 2 years of experience in the Quality or Engineering.
- Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook).
- Intermediate Skill Level in Microsoft Excel (conditional formatting, tables, formulas, charting).
- Working knowledge of government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485).
Benefits
- Health insurance
- Life and disability insurance
- 401(k) contributions
- Paid time off
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