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Danaher Corporation Quality Assurance Engineering Manager (Manufacturing) in Westborough, Massachusetts

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 Quality Assurance Manufacturing Team.

  • Responsible for the management or 4 Manufacturing QA Engineers and 3 QA Specialists, and the Incoming Inspection Supervisor.

  • Provide leadership to ensure the teams adequately support equipment qualifications, concessions / deviations, manufacturing investigations, product holds, MRB, control of nonconforming material, incoming inspections, risk management activities and manufacturing change control.

  • Use metrics management techniques to manage the team and the applicable processes.

  • Hold Team meetings to keep the team well informed as well as provide team support and motivation.

  • Remove obstacles encountered by the team and ensure appropriate team engagement to foster a positive work environment.

  • Provide team leadership to ensure change control documentation such as ECOs are executed with no negative impact on the quality of product produced post change implementation.

  • Provide team leadership to ensure effective investigations of manufacturing related issues and product 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.

  • Provide leadership and guidance to the teams regarding effective strategies for equipment qualification and process validations (IQ, OQ, PQ).

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

  • Review and approve concession and deviation requests. Participate in the Deviation and Concession Control Board.

  • Management the incoming inspection team (10 people) and inspection processes to ensure inspection lead times are adequate to meet manufacturing needs.

  • Supports and participates in the QMS Internal Audit program

  • Manages and monitors product holds to ensure proper execution and closure.

  • 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 10 years’ experience in an ISO 9001, medical device or pharmaceutical industry in an Engineering, Quality or Regulatory or R&D related role. Preferred to have 3-5 years leadership experience.

  • Experience in a regulated environment (preferred)

  • Strong communication and writing skills

  • Team Motivation and influential 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 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 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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