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Danaher Corporation Quality Specialist in Westborough, Massachusetts

Find what drives you on a team with a more than 70-year history of discovery, determination, and innovation. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers protect people. Our products serve a wide range of markets, so if your interests lie along the spectrum of Life Sciences to Industrial, you’ll find a rewarding role here. For the exponentially curious, Pall is a place you can thrive and amplify your impact on the world.

Pall 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.

Main Responsibilities:

  • Participates in developing Standard Operating Procedures (SOPs) and Work Instructions (WI) for Digital Innovation [DI] group to ensure quality objectives are met.

  • Revise Quality System procedures for Digital Innovation group

  • Provide training on the SOPs to the DI team.

  • Provide support for document control system.

  • Works closely with Automation engineers, Software engineers and product managers to define, establish and enforce documentation standard methodologies for projects within Digital Innovation group

  • Support the qualification activities for automation and software projects, including authoring/reviewing validation plan, qualification protocols, summary reports and change control documents.

  • Support execution of qualification protocols as needed.

  • Perform other Quality System support activities as needed.

  • Provide support for validation document reviews.

  • Stays current on regulatory requirements for automation and computer validation: GAMP V, 21 CFR Part 11

  • Travel – 20-25%

Minimum Requirements:

  • B.S. degree in a relevant Science or Engineering field. Other educational backgrounds considered when combined with understanding of the market and technical material

  • 5 years of working experience within Quality Assurance. Industrial experience in a regulated environment preferred

  • 1+ years of experience in validation activities

  • Good understanding of SDLC [Software Development Lifecycle] and CSV [Computer System Validation]

  • Well-developed interpersonal skills, both verbal and written.

  • Good understanding of different project execution methodologies: waterfall, agile, sprint/kanban

  • Experience managing both internal and vendor resources

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 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.

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 applyassistance@danaher.com to request accommodation.

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 applyassistance@danaher.com to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.

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