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 at Welldoc improving healthcare through software as medical devices. Supporting quality assurance and management processes in regulated medical environments.
Responsibilities
- A key member of the QA organization of a growing medical device company developing and manufacturing software as medical devices.
- Supports Quality Assurance activities related to product development and new product introduction activities.
- Supports Quality Management System (QMS) activities including processing of controlled documents, CAPA, complaints, supplier evaluations, and training.
- Process documentation requirements in support of Welldoc’s product development process.
- Updates and maintains training and configuration of controlled documents.
- Assign training requirements as specified in the QMS for on-boarding new employees.
Requirements
- Experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model, etc. in accordance to IEC 62304 and 21 CFR 820
- 3+ years’ experience with FDA and ISO regulated product development and ISO quality systems, including Design Controls, Production and Process Controls, CAPA and complaints
- Experience with MDSAP, ISO 13485, ISO 14971, FDA QSR (21 CFR Part 11, 21 CFR 820), Health Canada, TGA and EU MDR
- High attention to detail and meticulous record-keeping
- Ability to work both independently and as part of a highly integrated team
- Highly proficient in multitasking and project management and organization skills
- Excellent communication and problem-solving skills
- Comfortable working in a fast-paced and agile environment
Benefits
- generous PTO
- medical insurance
- dental insurance
- vision care
- life and disability insurance
- retirement benefits
- opportunity to participate in health savings accounts and/or dependent care accounts
Job title
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