Cytiva: Lead Quality Assurance Engineer (Design & Manufacturing)

Job Description Be part of something altogether life-changing Working at Cytiva in the Life Sciences industry means being at the forefront of providing new solutions to transform human health.

Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients.

With associates across 40 countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.

Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies.

Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

What you’ll do Provide Quality Assurance leadership to the manufacturing operations and/or the new product introductions teams.

This job depends on the individual and can be manufacturing focused or design controls focused or both.

Review change control documentation such as ECOs to ensure there is no negative impact on the quality of product produced post change implementation.

Conduct and coordinate manufacturing investigations related to manufacturing and design related failures.

Support the disposition of non-conforming products and components.

Identify nonconforming material trends and issue Quality Event Investigations Lead Root Cause Analysis of nonconformance incidents, including the documentation of completed investigations and CAPA plans.

Review and approved manufacturing related investigations and CAPAs owned by other departments.

Provide input into and be approver of manufacturing validation documentation (IQ, OQ, PQ).

Supports the development, implementation, and continuous improvement of process effectiveness and efficiency at the site.

Review and approve concession and deviation requests.

Participate in the Deviation and Concession Control Board.

Participate as member of design assurance teams to support the reliability of product designs, compliance to design requirements to support effective design transfers, product launches, and production ramp-ups.

Review, approve and provide input to design planning, verification / validation testing protocols & reports, and risk management documentation.

Participate as member of design assurance teams to ensure the reliability of product designs, compliance to design requirements to support effective design transfers, product launches, and production ramp-ups.

Supports and participates in the QMS Internal Audit program Implements and managed product holds.

Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, Lean Manufacturing, 5S, SPC, RCA, engineering studies, DOE, Gauge R& R, etc.

Identifies and reports any EHS, Quality or Compliance concerns and takes immediate corrective action or escalation as required.

Who you are Bachelor’s degree in engineering or health sciences field or other related degree.

Minimum 5 years’ experience in an ISO 9001, medical device or pharmaceutical industry in an Engineering, Quality or Regulatory or R& D related role Experience in a regulated environment (preferred) Basic understanding of materials, properties, manufacturing processes, and product assembly.

Ability to read and interpret professional journals, drawings and technical procedures.

Strong communication and writing skills Proficient with Microsoft tools; Word, Excel, Power Point, Project, Minitab, and Visio.

Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English.

Company Description Working at Cytiva in the Life Sciences industry means being at the forefront of providing new solutions to transform human health.

Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients.

With associates across 40 countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.

Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies.

Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.