Quality Assurance Engineer

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.

As we continue to grow as QuidelOrtho, we are seeking a Quality Assurance Engineer. The Quality Assurance Engineer Participates in the design and execution of all quality related deliverables per Quidel Quality Management System to support new product development. Drives product / process improvements through leading / assisting Corrective Action / Preventive Action activity. Provides direction to team utilizing quality derived industry standards for Risk Management and other cross functional Quality processes and procedures to support new product design / development. The incumbent may also lead corrective action / preventive action projects.

This position will be located onsite in Athens, OH

• Administers Master Validation Plans (MVP)

• Develops and maintains Risk Management Files (e.g. RM Plans, RM Reports, FMEAs, FTA, Hazard Analysis)

• Works with new product design trees

• Generates Change Orders as required to support New Product Development and/or CAPA projects.

• Assists in the development of Design Trace Matrices

• Determines experimental sampling plans.

• Develops and maintains Post Market Surveillance programs.

• Assists in transitioning product from development to manufacturing.

• Assists in development of raw material, production material and product specifications.

• Summarizes experimental data and draw conclusions.

• Maintains project documentation in accordance with internal Quidel and external regulatory requirements as part of the design control process.

• Participates actively with corrective action / preventive action projects in accordance with Quidel's Quality Management System

• Ensures the Quality Management System Standard Operating Procedures are in alignment with current Quality System Regulations

• Mentors Associate Quality Assurance Engineering staff

• Maintains a safe working environment.

• Carries out other duties as assigned in compliance with established business policies.

Required:

• Minimum of 3 years of experience in a QA Engineer role required, one of those years of experience in new product development / design control process.

• Project management experience, specifically working and managing timelines/ deliverables.

• Demonstrated knowledge of the essential aspects of project planning.

• Demonstrated knowledge regarding risk mitigation and risk management.

• Demonstrate knowledge of all aspects of Post Market Surveillance.

• Strong analytical and problem-solving skills.

• Good organizational skills, and the ability to manage multiple tasks.

• Ability to work within cross functional teams.

• Strong communication skills, written and verbal.

• Professionalism, confidence, maturity, and self-motivation.

• Capacity for decision making for new product development.

• Knowledge of relevant Quality and analytical tools.

• Planning and managing project deliverables.

• Working knowledge of manufacturing tools and processes (e.g. BOM, Routings, SPC Charts, Risk Management, Quality Test Plans and Master validation plans).

• Knowledge of related quality systems regulations and processes.

• Computer skills (e-mail, word processing, statistical, spreadsheet and graphing software).

• Ability to make decisions and build consensus for quality deliverables in support of New Product Development.

• Ability to function effectively under tight timelines and produce deliverables that pass all internal and external audits.

Preferred:

• BA/BS in Scientific field required, QE certification.

• Medical Device experience, or experience in a regulated field.

• Experience in experimental design

Internal: in R&D, Engineering, Quality Control, Quality Assurance, Operations, Supplier Quality Engineers, Process Engineers and Manufacturing Quality Engineers and Regulatory

External: Vendors, Suppliers and contractors

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

Position requires ability to lift up to 30 lbs. on a regular basis. Typically, 40% of time in meetings (attend ADHOC meetings is essential to this position); 60% of time at the desk on computer/doing paperwork/ on phone, doing analytical work. Walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Must be able to visually monitor products for Quality Standards. Position may be required to use Personal Protective Equipment as posted.

Essential functions are subject to change as other duties may be assigned.

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 .

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