QA Lead Engineer - Life Sciences Quality & Compliance

Cytiva; Umeå kommun; On-site; SEK 700,000 - 900,000; Full time

Job summary

Cytiva, a company focused on life sciences and biotechnology, seeks a QA Lead Engineer in Umeå, Sweden. The role coordinates quarterly inspections and collaborates with Manufacturing, Life Cycle Engineering, and Regulatory Compliance to implement design changes.

You will maintain certification documents and support ongoing electrical safety compliance. The ideal candidate has a degree inElectrical Engineering, strong project management experience, and proven ability to work in cross-functional

Qualifications

• Bachelor’s degree in Electrical Engineering or equivalent.
• Experience with electrical safety standards.
• Proven experience in project management and leading cross-functional improvement initiatives.
• Ability to work both independently and collaboratively.
• Strong communication skills in Swedish and English, written and spoken.
• Residing in Umeå or nearby area with the ability to commute to our site daily.

Responsibilities

• Coordinate and lead quarterly ETL, UL and MET audits in accordance with established processes
• Collaborate with certification bodies (e.g., Intertek) to maintain and update certification documentation, including CDRs
• Work cross-functionally with Regulatory Compliance and Life Cycle Engineering to initiate and implement design changes
• Ensure ongoing compliance with applicable electrical safety standards
• Contribute to ASME certification projects and provide CE, Customer Engineer support when required
• Support in other QA processes

Skills

Electrical safety standards

Project management

Cross-functional collaboration

Communication (Swedish & English)

Independent work

Education

Bachelor's degree in Electrical Engineering

Job description

Cytiva, a company focused on life sciences and biotechnology, seeks a QA Lead Engineer in Umeå, Sweden. The role coordinates quarterly inspections and collaborates with Manufacturing, Life Cycle Engineering, and Regulatory Compliance to implement design changes.

You will maintain certification documents and support ongoing electrical safety compliance. The ideal candidate has a degree inElectrical Engineering, strong project management experience, and proven ability to work in cross-functional