Senior Software Quality Engineer – Non-Product Software
Remote regions
USBenefits
Unlimited PTO
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Job Responsibilities:
- Support software validation and verification efforts to ensure compliance with FDA regulations.
- Own the quality approval process for software components, including documentation review and final release approvals.
- Act as the SME and work with the software product team to maintain, refine and improve the processes.
Minimum Requirements:
- Bachelor's degree in life sciences, engineering, or math preferred.
- 5 + years of quality experience in the pharmaceutical, biotech, or medical device industries.
- 3+ years of experience in non-product software validation within an FDA-regulated environment.
Required Knowledge, Skills and Abilities:
- Project management tracking and trending experience preferred.
- Strong understanding of FDA regulations, ISO 13485, and 21 CFR Part 11.
- Experience with auditor interaction in internal quality audits, regulatory inspections, and nonconformance investigations.
Sequel Med Tech
Sequel, headquartered in Manchester, New Hampshire, is developing the next generation of transformative drug-delivery advancements starting with diabetes. Sequel’s approach is to look at diabetes management holistically to advance systems that make living with diabetes simpler and easier for all. Sequel provides equal employment opportunities and believes that when you thrive, they thrive.