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 Director, Quality Control who is responsible for managing the quality control department functions, which include receiving inspection, in-process inspection, finished goods inspection, QC Chemistry and instrumentation triage. In addition, this position is responsible for directing, implementing, and continuously improving the quality controls and processes associated with manufacturing, returned goods, preventative and corrective actions, non-conforming materials, and inspection control plans. The Director, Quality Control also actively supports corporate strategic goals and objectives through manufacturing support, process improvement projects, and product development/ product improvement projects. This role acts as the primary operations liaison between manufacturing and QA/QS and ensures operations execution within the QA/QS requirements. This position will be located onsite in Carlsbad, CA.

• Leads efforts in managing the nonconforming material, process deviations, biological raw material testing, stability programs and customer complaint investigation functions

• Manages effective quality control systems through the identification, segregation, root cause analysis, corrective action, disposition and trending of product and process failures and inefficiencies

• Manages the expired materials control system to minimize scrap and maintain compliance

• Reviews material specifications, development of supplier/material qualification plans, and generation of inspection control plans

• Provides support to manufacturing in proactive resolution of quality issues, root cause failure analysis and troubleshooting

• Manages all aspects of manufacturing acceptance, in-process controls, DHRs batch record review, release of finished goods and intermediates

• Assures product traceability and record retention

• Leads departmental activities in significantly reducing product rejection, scrap and variances

• Works proactively with the operations staff to identify and correct quality problems with products and processes

Required Skills:

• Bachelor of Science or equivalent work experience and technical certification

• 10+ years of progressive QC Management responsibility

• Working knowledge of ISO 14385 Regulations, or some similar quality regulated quality system

• Experience with statistical techniques and Design of Experiment (DOE)

• Quality Tools - Problem Solving / Statistical Process Control / Process Capability / ISO 14385 / Design of Experiments / Sampling Plans / Root Cause Analysis

• Managerial Skills - Employee & Team Development / Career Development / Cost Accounting

• Excellent Communication Skills

• Advanced computer skills

• Project management skills

Preferred Skills:

• 8+ years of leadership experience preferred

• Medical device experience preferred

• Experience in a high-volume manufacturing environment preferred

Internal Partners:

Manufacturing, Engineering, R&D, Supply Chain, Facilities/Maintenance and Quality Assurance

External Partners:

Regulatory Agencies/Customers

The work environment characteristics are representative of an office, laboratory, and manufacturing environment and may include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues and samples. Flexible work hours to meet project deadlines.

No strenuous physical activity, though occasional light lifting of files and related materials is required. 50% of time in meetings, working with team, or talking on the phone, 50% of the time at the desk on computer, doing analytical work. Walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Position requires the 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 $135,700 to $250,000 and is bonus eligible or eligible for incentive compensation. 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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