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

As we continue to grow as QuidelOrtho, we are seeking a Senior Quality Engineer. The Senior Quality Engineer will provide compliance and technical support to Operations 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, CAPA and laboratory OOS.

The Senior Quality Engineer will collaborate with business partners to implement effective corrective/preventative actions. 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 onsite full-time in our Raritan, New Jersey location.

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

Track and trend quality data for non-conformances, RCI, CAPA and Change Control. Prepare data and present at Quality Systems Management Reviews

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

Provide quality engineering support to project teams in compliance with FDA, ISO and CMDR regulations and Orhto Quality System requirements

Mentor and train junior staff. Provide training to colleagues throughout the organization as required. Provide audit support through various roles such as subject matter expert, technical data preparation and scribe

The Individual

Required:

• B.S. Degree in Chemistry, Biochemistry, Biology, Chemical Engineering or a related discipline
• 5-7 years of experience in Quality, Regulatory and/or a highly regulated manufacturing environment. (Diagnostics, Medical Device, Pharmaceutical or Consumer)
• Have a background in investigation, root cuase and CAPAS
• Preventative and Predictive maintenance
• Up to 10% travel (as needed) - Domestic

Preferred:

• Validation experience if preferred.
• Ability to solve complex problems, make risk-based decisions and navigate through ambiguity.

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

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse 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.4

Physical Demands

Works for lengthy periods of time in sitting or standing position and for lengthy periods of time using a computer. Position may require travel, up to 10%, travel includes airplane, automobile travel and overnight hotel. At times, this role demands flexible work hours to meet deadlines, maintain system availability and support business continuity.

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 $90,000-$120,000 [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.

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].