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.

As we continue to grow as QuidelOrtho, we are seeking a Senior Manager, Quality Engineer to work at our San Diego office. This position is responsible for the successful transfer of new products from R&D into manufacturing. This will require an ability to develop appropriate acceptance criteria for product transfer. The position shall ensure that quality tools such as FMEA and Manufacturing Control Plans are effectively determined and implemented prior to product transfer. The position is also responsible for evaluating changes to existing products by assessing the acceptance criteria and ensuring no adverse impact on product performance. This position is an integral part of QuidelOrtho's product and process validation system. The position will support QuidelOrtho's Technical Support and Marketing teams by providing technical assistance related to product expectations and other quality considerations. The individual shall support and lead complex root cause failure investigation and troubleshooting of escalated product matters. Strong technical aptitude and experience (preferably in engineering, chemistry, biology or other life sciences field) is a must. High level of technical writing ability and excellent communication skills are required. The use of data in decision making is essential. Advance skills in statistical techniques and quality tools is a must. The individual shall ensure that appropriate support (coordination and as needed testing) towards establishing product shelf life along with ensuring that all requisite testing related to product performance characterization is completed. The ideal candidate is a champion of Quality System compliance with a deep understanding of medical device QSR's.

• FMEA - Ensure FMEAs for new and existing products are robust and complete. FMEAs are to be reviewed continually and updated as failure modes are identified.

• Control Plans - Ensure the control points that are proposed through the design and development process get evaluated for adequacy as related to field performance and manufacturability.

• Stability Studies - Support escalations related to stability study with new product launches and changes to existing product or regulation. Ensure adequate performance data related to pilot lots gets collected

• Complaints - Participate in Complaint Committee meetings and present investigation findings to peers and management.

• Represents the Quality Engineering department in evaluating readiness for product launch.

• Data analysis - Perform statistical analysis of data from experiments and manufacturing process trend monitoring.

• Participates in New Product team meetings and present findings and product aspects related to Quality Engineering.

• Pilot Lots - Establish and maintain pilot lot qualification program.

• Metrics - Ensure appropriate metrics get established to evaluate product health.

Required:

• FMEA - Ensure FMEAs for new and existing products are robust and complete. FMEAs are to be reviewed continually and updated as failure modes are identified.

• Control Plans - Ensure the control points that are proposed through the design and development process get evaluated for adequacy as related to field performance and manufacturability.

• Stability Studies - Support escalations related to stability study with new product launches and changes to existing product or regulation. Ensure adequate performance data related to pilot lots gets collected

• Complaints - Participate in Complaint Committee meetings and present investigation findings to peers and management.

• Represents the Quality Engineering department in evaluating readiness for product launch.

• Data analysis - Perform statistical analysis of data from experiments and manufacturing process trend monitoring.

• Participates in New Product team meetings and present findings and product aspects related to Quality Engineering.

• Pilot Lots - Establish and maintain pilot lot qualification program.

• Metrics - Ensure appropriate metrics get established to evaluate product health.

Internal Partners:

Product Development/R&D, Manufacturing, Quality Assurance Department Management and Personnel, Materials, Technical Support and Marketing

The work environment characteristics are representative of an office, laboratory and manufacturing environment. Flexible work hours to meet project deadlines and support of operational goals. Position requires ability to flexibly spend time on the desk, analyzing data, in meetings as well as hand-on product testing as needed. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Position requires use of Personal Protective Equipment as posted.

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 $100,000 to $175,000. 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.

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

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