Quality Engineer I
Company: Ortho-Clinical Diagnostics
Posted on: June 10, 2021
The Career Potential
Ortho Clinical Diagnostics is committed to improving and saving
lives with diagnostics. To do this we hire people who share this
dream and are ready for new adventures. As a valued team member,
you will carve your own career path and be part of building this
company stronger and better than ever before. There is no limit to
the experiences, opportunities and new directions you will have
access to here at Ortho Clinical Diagnostics. More importantly, you
will be driving the surge of a whole new direction in important
medicine. That's something we can all take pride in as we take this
Ortho is known in the industry as a leader in customer service
and support. Deeply understanding and exceeding the needs of our
clinical lab, hospital and blood bank customers is what we do. It's
who we are. If you join Ortho, no matter what your role, you will
be expected to keep that Customer Excellence focus in your
As the company continues to grow we are seeking a Quality
Engineer I to work in our manufacturing facility building 313. The
Quality Engineer I will provide quality engineering support to
Quality and Operations staff on all aspects of the manufacturing
process at the Rochester Manufacturing Site. The candidate will
work to resolve nonconformances by ensuring adequate RCIs are
conducted and effective CAPAs are implemented. The candidate will
utilize key Quality Engineering principles, tools, and practices to
develop and optimize process controls and quality system processes
and identify opportunities to improve quality and cost that are
aligned with the overall business goals and Ortho's Quality Policy.
The candidate will accurately assess risk and will drive quality
This position is in Rochester, NY.
Partner with operations to evaluate and address quality events
including nonconformances, product dispositions, root cause
investigations, and implement appropriate CAPA based on risk level.
Analyze and monitor key quality metrics and develop action plans to
address unfavorable trends.
Promote continuous improvement activities by seeking out
opportunities to optimize processes and systems to reduce variation
and improve product quality. Drive implementation of best practices
to eliminate repeat quality events and improve product quality.
Support product and process root cause investigations by
collaborating with product support, engineering, and
Support and participate in inspection readiness activities by
applying working knowledge of ISO13485 and 21CFR Part 820
- Provide coaching, training, and technical guidance to business
partners in aspects of the company quality system requirements as
they pertain to manufacturing quality and provide guidance of
effectively applying key quality engineering principles and
B.S. Degree in Chemistry, Biochemistry, Biology, Engineering, or
a related discipline.
1-3 years of experience in Quality in a highly regulated
manufacturing environment (Diagnostics, Medical Device,
Pharmaceutical, or Consumer).
Advanced Microsoft Office (Word, Excel, PowerPoint, etc.) tools
experience for communications, reporting and data analysis is
- Required Travel- Less than 10%.
Keywords: Ortho-Clinical Diagnostics, Rochester , Quality Engineer I, Other , Rochester, New York
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