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Senior Software Quality Engineer, Bedford
Client: Werfen
Location: Bedford, United Kingdom
Job Category: Other
EU work permit required: Yes
Job Reference: 629487106c3f
Job Views: 7
Posted: 19.08.2025
Expiry Date: 03.10.2025
Job Description:
Overview
The Senior Software Quality Engineer is responsible for ensuring that activities throughout the product lifecycle comply with applicable procedures, standards, and regulations. The role involves developing, applying, and implementing methods, tools, and practices while working with project teams to achieve quality goals in design, development, cybersecurity, verification, validation, maintenance, and service. It requires advanced skills in analyzing information, reviewing technical reports, promoting process improvements, requirements development, risk management, product development, verification, validation, and cybersecurity.
Responsibilities
Key Accountabilities
* Participate in generating quality documents throughout the product lifecycle.
* Advise and direct teams on compliance with procedures, standards, and regulations; implement changes as regulations evolve.
* Ensure product quality meets requirements and documentation is complete before approval.
* Support new product development or design change projects.
* Review and approve quality documents during the product lifecycle.
* Support audits and corrective actions to maintain compliance of the QMS.
* Identify compliance gaps and implement corrective actions.
* Lead or participate in quality system improvement projects.
* Perform other duties as assigned, with reasonable accommodations for individuals with disabilities.
Budget Managed: N/A
Internal Networking/Key Relationships:
* Collaborate with other functions to generate compliant documents by interpreting quality procedures, standards, and regulations.
* Communicate quality requirements effectively to various stakeholders.
* Negotiate and influence to improve quality and compliance.
Skills & Capabilities:
* Knowledge of domestic and international quality/regulatory standards.
* Familiarity with quality management techniques (Lean, Six Sigma) and statistical methods.
* Understanding of products, technology, manufacturing processes, and their impact on customers and patients.
* Judgment regarding regulatory data review, reports, design changes, and risk management to ensure compliance and business objectives.
Qualifications
Minimum Knowledge & Experience:
* Bachelor’s degree or equivalent in engineering or science.
* At least 8 years of experience in medical devices, pharmaceuticals, diagnostics, or clinical laboratories, or 5 years of relevant experience.
International Mobility Required: No
Travel Requirements: Approximately 10%
If interested in this challenging role with opportunities for continuous learning, please submit your resume or CV. Werfen is an Equal Opportunity Employer committed to diversity and prohibits discrimination and harassment. For accommodations, contact us for assistance. We operate in over 30 countries, with an annual revenue of approximately $2 billion and over 7,000 employees worldwide.
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