Quality Engineer II
Rochester, NY 
Posted 17 days ago
Job Description
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 journey together.

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 work.

The Opportunity

As the company continues to grow we are seeking a Quality Engineer II. The Quality Engineer II 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 related decisions.

This position is in Rochester, NY.

The Responsibilities

  • 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 operations.

  • Support and participate in inspection readiness activities by applying working knowledge of ISO13485 and 21CFR Part 820 regulations.

  • 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 tools.

The Individual
  • B.S. Degree in Chemistry, Biochemistry, Biology, Engineering, or a related discipline.

  • 3-5 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.

  • Required Travel: Less than 10%

EOE/AA Disability/Veteran

"At Ortho Clinical Diagnostics, we are proud of the empowering, inclusive and innovative culture we are growing. Our team is passionate about our work, and brings deep knowledge, industry experience and diverse thinking that drive results, making Ortho a place to grow your career.

Ortho Clinical Diagnostics is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other characteristic protected by law."


Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
3 to 5 years
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