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 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 Role

As we continue to grow as QuidelOrtho, we are seeking a Quality Engineer. This position is responsible for owning and coordinating all Quality Engineering functions and activities for the defined processes. This individual is also responsible for supporting the Production, Quality Control, Engineering and Quality Assurance departments and the associated activities, which include receiving inspection, in-process inspection, and finished goods inspection in achieving and exceeding company goals and objectives. In addition, this individual is responsible for supporting the administration, implementation, and continuous improvement of the quality systems associated with non-conforming materials, inspection control plans, and corrective/preventive action. This individual also supports corporate strategic goals and objectives through internal audits, support of manufacturing operations, quality support for manufacturing processes for new product development/ product improvement projects, and support of manufacturing process improvement projects.

This position will be onsite full-time at our Carlsbad, CA (Rutherford) location.

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. FMEA’s).
• 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.
• Perform 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+ 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.
• Preferred, knowledge of current and applicable GMP regulations including ISO13485 and 21 CFR Part 820.
• Ability to travel up to 5%.

The Key Working Relationships

Internal Partners:

• All levels of the organization.

External Partners:

• Vendors and Customers.

The Work Environment

If the work environment is mainly typically in the lab/warehouse/production line, use verbiage like:

The work environment characteristics are representative of a manufacturing, warehouse and office 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.

Physical Demands

Up to 75% at desk, on manufacturing floor, walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role; 25% of time in meetings or on the phone. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Must have the ability to operate lab equipment. Position requires use of Personal Protective Equipment as posted.

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, 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 $80,000 to $85,000. 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 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 [email protected].