Quality Engineer II

The Opportunity

Quidel Ortho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

As we continue to grow as Quidel Ortho, 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 opportunity is located 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 operations.

• Support and participate in inspection readiness activities by applying working knowledge of ISO
  13485 and 21
  
  CFR 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.

• Perform other work-related duties as assigned

Required:

• 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.

Preferred:

• Clearly and effectively documents, communicates, and presents technical information.

• Works effectively independently as well with a cross-functional team across Operations, Product Support, Compliance, Regulatory, and Suppliers.

• Demonstrates a high degree of accuracy and attention to details

• Strong organization and time management skills.

• Analytical and problem-solving skills with an ability to use scientific knowledge and statistical methods to identify and resolve issues.

• Knowledge of current and applicable GMP regulations including ISO
  13485 and 21 CFR Part 820

Internal Partners: Operations, Engineering, Product Support, Laboratory Personnel, Regulatory Affairs, and Compliance

External Partners: Regulatory Agencies

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Working around moving…