Senior 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:

The Senior Quality Engineer is focused on Quality oversight of the manufacturing of in vitro diagnostic medical devices. This position has specialized subject matter expert knowledge of the manufacturing process and Quality Systems and mentors/trains other personnel. The Senior Quality Engineer drives quality related decisions, with appropriate approval authority (both data-based and risk-assessment based decisions). This position requires a large degree of independent decision making.

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 QuidelOrtho’s Quality Policy. The Senior Quality Engineer will collaborate with business partners to address quality events/nonconformances to rapidly investigate and disposition material. The individual has accountability to oversee, coordinate and execute all of the required activities for end to end for the manufacturing quality processes. This role will support/lead projects providing quality/SME guidance.

This role will author, document, and review quality record documentation. The Senior Quality Engineer will ensure audit readiness programs are effectively implemented within the organization. This includes supporting/leading through various roles such SME, technical data preparation, etc. The work should be performed to ensure compliance with company and regulatory requirements (GMP, ISO, IVDR etc.) along with QuidelOrtho core behaviors. This role develops and maintains effective working relationships with peers and business partners. The Senior Quality Engineer is a problem solver and critical thinker in all aspects of the role while navigating ambiguity and range of medium to high complexity of issues.

This role will be located onsite in San Diego.

The Responsibilities:

• Leads, mentors, trains, and influences the other quality personnel

• Has the responsibility to approve disposition for product in accordance with defined procedure and/or utilizing a risk-based approach. Performing containment activities as needed.

• Demonstrates advanced problem-solving skills. Identifies and resolves problems in a timely manner. Gathers and analyzes information skillfully. Develops alternative solutions effectively. Analyzes technical data and proposals.

• 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.

• Lead the charge on continuous improvement activities by seeking out opportunities to optimize processes and systems to reduce and control variation.

• Drive product and process root cause investigations by leading, facilitating, and collaborating with product support, engineering, and operations.

• Lead and participate in inspection readiness activities by applying working knowledge of applicable ISO13485, 21CFR Part 820 and IVDR regulations.

• Conduct product risk assessments and initiate/manage Product Risk Files (i.e. FMEA’s).

• Support change control process (authoring/collaborating/approving).

• 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 and problem-solving techniques to support/promote QO Improvement culture

• 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.

• 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.

• Knowledge of current and applicable regulations including ISO13485, 21 CFR Part 820, and IVDR or equivalent experience.

Preferred:

• Preferred 5+ years of experience in Quality in a highly regulated manufacturing environment (Diagnostics, Medical Device, Pharmaceutical, or Consumer) or an equivalent combination of education and experience.

Key Working Relationships:

Internal:

Operations, Engineering, Product Support, R&D, Complaint Handling Unit, Laboratory Personnel, Regulatory Affairs

External:

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 maybe required. Travel includes airplane, automobile travel and overnight hotel.

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 $92,000 - $156,000 annually. 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 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 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 [email protected].

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