Senior Software Quality Engineer
Responsibilities
- Participates in the generation of quality documents throughout the product lifecycle.
- Advises and directs teams regarding compliance to procedures, standards and regulations.
- Implement changes to procedures in alignment with evolving regulations.
- Ensures product quality meets requirements and documentation is complete prior to approval.
- Participates on core teams supporting new product development or design changes.
- Reviews and approves quality documents throughout the product lifecycle.
- Supports audits and corrective actions to improve and maintain compliance of the QMS.
- Identifies compliance gaps and takes appropriate corrective actions as needed.
- Participates in and may lead quality system improvement projects as required.
- Performs other duties and responsibilities as assigned.
Qualifications
- Education: Bachelor’s degree or equivalent in engineering or science.
- Experience: A minimum of 8 years of experience in medical devices, pharmaceuticals, diagnostic industry, or clinical laboratory.
Benefits
- Medical, dental, and vision insurance.
- 401(k) plan retirement benefits with an employer match.
- Paid vacation and sick leave.
Pay
The annual base salary range for this role is currently $130K - $160K. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.
Schedule
Approximately 10%
Company Information
Werfen is a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.