Cytiva
life sciences, diagnostics and biotechnology
SeniorQualityEngineerProjects
“Senior Quality Engineer- Projects at Cytiva. Skills: Quality Engineering Projects, Risk Mitigation, Regulatory Compliance, Problem Solving. Support execution of high-impact, cross-functional priority quality engineering projects. Ensure compliant delivery aligned with QMS, regulatory, and customer requirements”
What You'll Achieve.
Ensure compliant delivery aligned with QMS, regulatory, and customer requirements; Implement sustainable solutions; Drive quality, delivery, and risk mitigation outcomes; Demonstrate project effectiveness through defined KPIs; Support audit readiness and execution
Industry & Context.
Structured problem solving (RCA, CAPA, risk assessments, statistical analysis); Identify root causes and implement sustainable solutions; Analyze quality and process data to identify trends
Ability to travel 15 % travel, overnight, within USA and internationally, Must have a valid driver’s license with an acceptable driving record, Ability to lift, move or carry equipment up to 50lb
What They're Looking For.
Must Have
Bachelor's degree in Engineering or 5 years engineering experience, Additional 3–5 years of experience in Quality Engineering or Manufacturing Engineering within an ISO 13485 or highly regulated environment, Able to apply knowledge of QMS, ISO 9001, ISO 13485, FDA/cGMP requirements, into risk-based thinking, writing controlled documents, change control and performing quality event investigations, Proficient in Lean, Six Sigma, SPC, MSA, and Gage R&R methodologies
Nice to Have
Experience in filtration, membranes, or bioprocessing manufacturing environments, Exposure to analytical chemistry, microbiology, contamination control, sterilization, or ISO 17025 environments, Used systems such as SAP, Veeva, Magic, or Oracle
What You'll Do.
Support execution of high-impact
cross-functional priority quality engineering projects
Ensure compliant delivery aligned with QMS
and customer requirements
Apply structured problem solving (RCA
statistical analysis) to identify root causes and implement sustainable solutions
Analyze quality and process data to identify trends
support decision-making
and demonstrate project effectiveness through defined KPIs
Support audit readiness and execution (internal
and customer) related to quality engineering initiatives
How You'll Work.
Team & Collaboration
Partner with Manufacturing, Engineering, Supply Chain, R&D, and Regulatory teams to drive quality, delivery, and risk mitigation outcomes; Influence across functions and communicate clearly at all levels
Communication Scope
Communicate clearly at all levels
Process & Methodology
Support execution of high-impact, cross-functional priority quality engineering projects
Applying for this Senior Quality Engineer- Projects role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Cytiva?
Real rants from real employees. Read before you apply.