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 II.

The Quality Engineer II will provide compliance and technical support to Manufacturing on all aspects of the biological manufacturing process controls at the Raritan manufacturing site for the Transfusion Medicine line of business. Utilize key Quality Engineering (QE) principles, tools, and practices to develop and optimize process controls and quality system processes that are aligned with the overall business goals and Ortho's Quality Policy. Partner with manufacturing to implement process improvements and address quality events including non-conformance, product disposition, root cause investigation, and laboratory OOS. Collaborate with business partners to implement effective corrective/preventative action. Author, document, review quality record documentation including NC, RCI, FI and other areas of quality engineering/validation, spreadsheet validation, and equipment qualification. Assure inspection readiness programs are effectively implemented within the organization. Execute functions needed to support change control and document management. Drive quality related decisions, with appropriate approval authority (both data-based and risk-assessment-based decisions). Utilize multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), and international organization for standardization (ISO).

This position will be working onsite in Raritan, NJ.

The Responsibilities

• Partner with manufacturing to implement process improvements and address quality events including non-conformances, root cause investigation, product disposition. Utilize process excellence tools as appropriate.
• Quality representative for teams conducting investigations related to non-conformances and/or customer complaints. Escalate issues per established procedures. Apply CAPA process through completion and approval of non-conformances, RCI and CAPA
• Demonstrate 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.
• Track and trend quality data for non-conformances, RCI, CAPA and Change Control. 10%Provide quality engineering support to project teams in compliance with FDA, ISO and CMDR regulations and QO System requirements.
• Organize and present technical information.
• Work with cross-functional teams, including technical and non-technical work.
• Provide input and generate metrics in support of QSMR, IRB, MRB, and Product Quality review.
• Perform other work-related duties as assigned.

The Individual

Required:

• B.S. Degree in Chemistry, Biochemistry, Biology, Chemical Engineering or a related discipline.
• 3+ years of experience in Quality, Regulatory and/or a highly regulated manufacturing environment (Diagnostics, Medical Device, Pharmaceutical or Consumer).
• Up to 10% travel when necessary - Domestic

Preferred:

• Nice to have skills

The Key Working Relationships

Internal Partners:

• Partner with Manufacturing, Product Support, Microbiology, Regulatory Affairs, Quality Control Labs, Engineering and Compliance.

External Partners:

• Support/participate in external regulatory audits (FDA, TUV, Health Canada, Customers, etc.)

The Work Environment

No strenuous physical activity, though occasional light lifting of files and related materials is required. 30% of time in meetings, working with team, or talking on the phone, 70% of the time at the desk on computer, doing analytical work. Minimal travel 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 $57,000 to $98,000. 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 .

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