Senior Software Quality Engineer

New Today

The Senior Software Quality Engineer ensures compliance with applicable procedures, standards, and regulations across the product lifecycle for software-based products. This technical role involves independently developing and implementing quality tools, processes, and practices to support product design, development, cybersecurity, verification and validation, maintenance, and service.
Key Responsibilities:
Create, review, and approve quality documentation throughout the product lifecycle.
Guide teams on regulatory compliance and implement procedural updates as regulations evolve.
Ensure products meet quality requirements and documentation is complete before approvals.
Participate in and support new product development and design change projects.
Identify and address compliance gaps; support audits and corrective actions.
Lead or contribute to quality system improvement initiatives.
Provide technical input in areas such as risk management, V&V, and cybersecurity.
We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf) .
To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .
Skills and Requirements
Bachelors degree (or equivalent) in engineering or science; or relevant experience in lieu of degree.
Minimum 8 years of experience in medical devices, pharmaceuticals, diagnostics, or clinical labs; or 5 years with strong relevant background.
Working knowledge of domestic and international quality and regulatory standards - 62304 SW Eng and RISK - 14971
Familiarity with quality management and statistical techniques (e.g., Lean, Six Sigma).
Understanding of product technologies, manufacturing processes, and their impact on customers/patients.
Demonstrated ability to apply regulatory requirements to data analysis, risk management, and design changes.
Strong grasp on Middleware solutions - Medical Device Data management experience - Experience with tools: Jira, ALM, JAMA,
Experience with: SAP - QMS
Hands-on experience with regulatory audits or inspections.
Experience driving process improvements in quality systems.
Knowledge of customer and patient-centered design in medical product development.
Experience writing code or C++ null
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.
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Location:
Bedford, MA, United States
Category:
Computer And Mathematical Occupations

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