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Danaher Corporation Lead Quality Assurance Engineer (Design & Manufacturing) in Westborough, Massachusetts

Help us improve access to life-changing therapies that can transform human health

We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020.

Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes.

We are looking for a Lead Quality Assurance Engineer (Design & Manufacturing) to work with our expert Quality team of employees across the world. Do you have a passion for Quality ​? Then we would love to hear from you.

What you’ll do

  • Provide Quality Assurance leadership to the manufacturing operations as well as the new product introductions teams.

  • Review, approve and provide input to design planning, verification / validation testing, 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.

  • 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 7 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

  • 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 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.

Who we are

Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you’ll feel right at home here. If you’re flexible, curious and relentless, you’ll belong. If you are excited about a global culture, this can be the place to further your career.

Want to know more? Experience life at Cytiva on our Careers website (https://jobs.danaher.com/global/en/cytiva) , Instagram channel (https://www.instagram.com/cytiva/) and LinkedIn page (https://www.linkedin.com/company/cytiva/) !

Cytiva is global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to advance and accelerate therapeutics. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients.

Cytiva is part of the Danaher family of companies, a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .