Quality Assurance Engineer

  • Cytiva
  • Eysins, VD, Switzerland
  • 18/05/2021
Full time Data Science Data Engineering Data Analytics Big Data Data Management Statistics

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 engineering support to the manufacturing operations as well as the new product introductions teams.
Engineer position for leading and supporting QA Engineering activities with Technical Functions such as R&D, Manufacturing Engineering and Production.
Review, approve and provide input to design planning, verification / validation testing, and risk management documentation.
Participate as member of design control teams to ensure the reliability of product designs, compliance to design requirements to support effective design transfers, product launches, and production ramp-ups.
Review change control documentation such as ECOs to ensure there is no negative impact on the quality of product produced post change implementation.
Ability to analyze process and design related data and draw appropriate conclusions using statistical methods (when appropriate).
Conduct and coordinate manufacturing investigations related to manufacturing and design related failures.
Lead Root Cause Analysis of nonconformance incidents, including the documentation of completed investigations, CAPA plans and support to Quality letters.
Review and approved manufacturing related investigations and CAPAs owned by other departments.
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.
Supports and participates in the QMS Internal Audit program
Identifies and reports any EHS, Quality or Compliance concerns and takes immediate corrective action or escalation as required.
Implements and managed product holds and field actions.
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.

Who you are
Bachelor’s degree in engineering or health sciences field or other related degree.
Minimum 5 years’ experience in an ISO 13485, medical device or pharmaceutical industry in an Engineering, Quality or Regulatory or R&D related role
Experience in a regulated environment and knowledge of equipment intended for GMP use
Demonstrated understanding of product development lifecycles, design change, document change control, process verification and validation methodologies, manufacturing/production process control methodologies, and servicing in a medical device environment.
Basic understanding of materials, properties, manufacturing processes, and product assembly.
Ability to read and interpret professional journals, drawings and technical procedures.
Strong investigation and root cause analysis skills and an ability to write robust CAPA plans.
Good strong QA process knowledge with an emphasis on technical skills to ensure understanding of technical data and information.
Experience of device/instrument hardware and software and any experience in single use disposable kits is desirable
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.

When you join us, you’ll also be joining Danaher’s global organization, where 68,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.

If you’ve ever wondered what’s within you, there’s no better time to find out.