Lead Quality Assurance Engineer (Design & Manufacturing)
Company: Danaher Corporation
Location: Westborough
Posted on: February 25, 2021
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Job Description:
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, Instagram channel and
LinkedIn page! 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.
Keywords: Danaher Corporation, Worcester , Lead Quality Assurance Engineer (Design & Manufacturing), Engineering , Westborough, Massachusetts
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