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 Quality Engineer. This position is responsible for the successful transfer of new products from R&D into manufacturing which requires the ability to develop appropriate acceptance criteria for product transfer. The Sr. Quality Engineer, New Products ensures that quality tools such as Failure Mode and Effects Analysis (FMEA) and Manufacturing Control Plans are effectively determined and implemented prior to product transfer. The position acts as a key member of Quidel's Validation Review Committee by evaluating changes to existing products, assessing the acceptance criteria, and ensuring no adverse impact on product performance. This role plays an integral part with Quidel's product and process validation system and supports Quidel's Technical Support and Marketing teams by providing technical assistance related to product expectations and other quality considerations.

This position will be located onsite in San Diego, CA.

• Ensure FMEAs for new and existing products are robust and complete. Continually review and update FMEAs as failure modes are identified

• Ensure the control points proposed through the design and development process are evaluated for adequacy as related to field performance and manufacturability

• Support escalations related to stability study of new product launches and/or changes to existing product or regulations

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

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

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

• Participate in New Product team meetings and Validation Review Committee meetings (VRC).

• Support and lead complex root cause failure investigation and troubleshooting of customer complaints and product nonconformances within manufacturing

• Monitor field complaint data to evaluate new product performance and the impact of changes

Required skills:

• 6-8 years' experience in Quality and Manufacturing Systems in Medical Device and high-volume manufacturing environments

• Quality Engineering skills which include FMEA, Control Plans, Acceptance criteria, Sampling Plans.

• Strong technical aptitude and experience (preferably in engineering, chemistry, biology or other life sciences field) is a must.

• Quality Tools - Problem Solving Methodologies/Process Capability / ISO 13485 / Design of Experiments.

• Ability to communicate effectively with all levels of employees throughout the organization

• Ability to develop and maintain strong working relationships with internal and external customers

• Proficient in Microsoft Office, statistical software programs, operating systems, voice and email, etc.

• Ability to lead and facilitate a group of technical experts in root cause investigations

• Knowledge of quality systems and regulations for medical device industry.

• High level of technical writing ability and excellent communication skills

• Advanced skills in statistical techniques and quality tools

• Understanding of medical device Quality System Regulations (QSR)

Preferred Skills:

• B.S. in Engineering/Chemistry/Biology/Technical Discipline or equivalent combination of certification and work experience

• Minimum 3 years' experience in New Product introductions

• ASQ Quality Engineer Certification (CQE)

Internal: Product Development/R&D, Manufacturing, Quality Assurance, Technical Support and Marketing

External: Materials

The work environment characteristics are representative of an office, laboratory and manufacturing environment.

75% of the time the position requires the ability to spend time on the desk, analyzing data, in meetings as well as hand-on product testing as needed. Flexible work hours to meet project deadlines and support of manufacturing goals. 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 $78,600 to $145,000.00. 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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