Danaher Corporation Lead Quality Assurance Engineer (Design & Manufacturing) in Westborough, Massachusetts
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 as well as the new product introductions teams.
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.
Lead the Material Review Board Meetings. Coordinate 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.
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.
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.
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 (https://www.danaher.com/how-we-work/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.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 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 (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at 202.419.7762 or email@example.com to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.