Senior Quality Engineer

The Opportunity

QuidelOrtho 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.

The Role

As we continue to grow as QuidelOrtho, we are seeking a Senior Quality Engineer who 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 apply statistical tools and sampling methodologies when evaluating quality events and developing appropriate CAPA monitoring plans. The candidate will accurately assess risk and will drive quality related decisions.

This position will be onsite full-time at our Rochester, NY facility.

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. Properly assess risk of quality events and ensure that appropriate and timely mitigations (short and long-term) are implemented. Analyze and monitor key quality metrics and develop action plans to address unfavorable trends.
• Lead and 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.10%Support and participate in inspection readiness activities by applying working knowledge of ISO13485 and 21CFR Part 820 regulations.
• Mentor and train junior quality engineering staff in application of quality engineering principles. 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.
• Clearly and effectively documents, communicates, and presents technical information.
• Perform other work-related duties as assigned.

The Individual

Required:

• B.S. Degree in Chemistry, Biochemistry, Biology, Engineering, or a related discipline
• 5-7 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.
• Works effectively independently under limited supervision as well with a cross-functional team across Operations, Product Support, Compliance, Regulatory, and Suppliers.
• Ability to navigate complex and ambiguous quality issues and appropriately assess risk.
• Demonstrates a high degree of accuracy and attention to details.
• Excellent analytical and problem-solving skills with an ability to use scientific knowledge and statistical methods to identify and resolve issues.
• Strong organization and time management skills.
• Knowledge of current and applicable GMP regulations including ISO13485 and 21 CFR Part 820.

The Key Working Relationships

Internal Partners:

• Partner with Operations, Engineering, Product Support, Laboratory Personnel, Regulatory Affairs, and Compliance.

External Partners:

• Regulatory Agencies.

The Work Environment

No strenuous physical activity, though occasional light lifting of files and related materials is required. 30% of time in meetings, working with team, or talking on the phone, 70% of the time at the desk on computer, doing analytical work. Minimal travel required. Travel includes airplane, automobile travel and overnight hotel.

Salary Transparency

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 for this position is $80,000 to $136,000. 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.

Equal Opportunity

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 the 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.