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 6000 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

We are seeking a Quality Engineer to join our Quality and Operations team. The Quality Engineer will provide support to Quality and Operations on all aspects of the manufacturing process. The position will work to resolve quality issues by ensuring adequate root cause investigations conducted and verifying effectiveness of CAPAs implemented. The position 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 QuidelOrthos Quality Policy. The position will assess risk and will drive quality-related decisions.

This role will be located onsite in San Diego CA (Summers Ridge).

The Responsibilities

• Partner with operations to evaluate and address quality events including nonconformances product dispositions customer complaints root cause investigations and implement appropriate corrections and/or corrective actions based on risk level. Analyze and monitor key quality metrics and develop action plans to address unfavorable trends.

• Promote continuous improvement activities by seeking out opportunities to optimize processes and systems to reduce and control variation.

• 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.

• Conduct product risk assessments and manage Product Risk Files (i.e. FMEAs).

• Support change control process. Collaborate with R&D on design transfer activities / plans that may include but are not limited to the development of raw material specifications process controls and validation.

• Utilize quality engineering tools such as performing design of experiments gage R&R and process capability assessments.

• Performs other work-related duties as assigned.

The Individual

Required:

• B.S. Degree in Chemistry Biochemistry Biology Engineering or a related discipline or an equivalent combination of education and experience.

• Preferred 1-3 years of experience in Quality in a highly regulated manufacturing environment (Diagnostics Medical Device Pharmaceutical or Consumer).

• Advanced Microsoft Office (Word Excel PowerPoint etc.) and other statistical software tools (e.g. MiniTab).

• Experience with establishing sample plans quality test plans and summarizing / reporting data analysis is required.

• Clearly and effectively documents communicates and presents technical information.

• Works effectively independently as well with a cross-functional team across Operations Product Support Compliance Regulatory and Suppliers.

• Demonstrates a high degree of accuracy and attention to details.

• Strong organization and time management skills.

• Analytical and problem-solving skills with an ability to use scientific knowledge and statistical methods to identify and resolve issues.

• This position is not currently eligible for visa sponsorship.

Preferred:

• Knowledge of current and applicable GMP regulations including ISO13485 and 21 CFR Part 820.

Internal Customers:

• Operations

• Engineering

• Product support

• Laboratory personnel

• Regulatory Affairs

• Compliance and Regulatory Agencies

The Work Environment

The work environment characteristics are representative of both an office and manufacturing environment. Flexible work hours to meet project deadlines. Occasional travel may be required. Travel includes airplane automobile travel and overnight hotel.

The Physical Demands

• Temperature: Extreme heat or cold

• Noise level: Sounds or a pitch that may cause distraction

• Location: Inside or outside such as an office or outdoors

• Weather: Wet and/or humid conditions outside weather conditions

• Exposures: Hazardous materials fumes toxic chemicals airborne particles odors or other unpleasant surroundings

• Workspace: Traditional workspace or remotely

• Other factors: Frequent overtime extensive travel emergency staff designations or being on-call Sitting standing walking lifting carrying reaching pushing and pulling.

• Other physical demands include bending crawling stooping vision grasping climbing or balancing kneeling crouching talking or hearing tasting or smelling.

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 its is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. The salary range for this position is $80000 to $100000 and is bonus 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 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 .

#LI-AC1