Senior Quality Engineer (Rochester, NY)

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 Opportunity

As the company continues to grow we are seeking a Senior Quality Engineer. The Senior Quality Engineer will provide quality engineering support at the Rochester site.

The Senior Quality Engineer 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 root cause investigations are conducted and effective corrective and preventive actions 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 QuidelOrtho'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 based out of our Rochester, New York 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.
• 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.

The Individual

• 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.

Key Working Relationships

• Internal Partners : Planning, Quality Engineering and Product Support.
• External Partners : customers and vendors.

The Working Environment

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.

Up to 75% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines.

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.

The salary range for this position is $95,000 to $105,000. 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 Employment 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 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 [email protected]