Quality Engineer II

As we continue to grow as QuidelOrtho, 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 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.

• 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 ISO13485 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 machinery. Protective equipment required, as needed.

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range is $68,000.00 to $116,000.00 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com.

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