Bedford, Massachusetts, United States Employment USD 130,000 - 160,000 Yearly

Werfen is hiring a Senior Software Quality Engineer

About the Role

Werfen is hiring a Senior Software Quality Engineer to ensure all activities throughout the product lifecycle comply with established procedures, standards, and regulations. This technically focused role develops and applies methods to achieve quality goals in design, development, cybersecurity, verification, and validation.

What You'll Do

  • Participate in generating quality documents throughout the product lifecycle.
  • Advise and direct teams on compliance to procedures, standards, and regulations, implementing changes as regulations evolve.
  • Ensure product quality meets requirements and documentation is complete prior to approval.
  • Participate on core teams supporting new product development or design changes.
  • Review and approve quality documents throughout the product lifecycle.
  • Support audits and corrective actions to improve and maintain compliance of the Quality Management System (QMS).
  • Identify compliance gaps and take appropriate corrective actions as needed.
  • Participate in, and may lead, quality system improvement projects.

What We're Looking For

  • Bachelor’s degree or equivalent in engineering or science.
  • A minimum of 8 years of experience in medical devices, pharmaceuticals, diagnostic industry, or clinical laboratory; or 5 years of experience.

Benefits & Compensation

  • Salary range: $130K - $160K
  • Medical, dental, and vision insurance
  • 401k plan retirement benefits with an employer match
  • Paid vacation and sick leave

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law.

Required Skills
Software Quality EngineeringMedical DevicesPharmaceuticalsDiagnosticsClinical LaboratoryQuality SystemsRegulatory ComplianceTest Automation
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About company
Werfen

Werfen is a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through its OEM business line, it researches, develops, and manufactures customized assays and biomaterials.

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Job Details
Department Quality Assurance
Category qa_testing
Posted 14 days ago