Senior Quality Engineer

San Diego, CA, United States

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 Assurance Engineer. The purpose of this position is to professionally interact and participate in the design and execution of all quality related deliverables per QuidelOrtho Quality Management System to support new product development. Drive product / process improvements through leading / assisting Corrective Action / Preventive Action activity. Provide direction and training to team members for Risk Management and other cross functional Quality type procedures and processes to support new product development. Carries out other duties as assigned in compliance with established business policies.

This position will be located onsite in San Diego, CA

The Responsibilities Responsibilities include supporting new product design / development activities utilizing internal and external quality derived industry standards. The incumbent may also lead corrective action / preventive action projects.

Administering Master Validation Plans (MVP)

Develop Risk Management File

Develop new product design trees

Generate Change Orders as required to support New Product Development and/or corrective / preventive action projects.

Monitor Development Trace Matrix requirements

Determine experimental sampling plans

Assist in transitioning product from development to manufacturing

Develop qualification test plans for new raw materials, injection molded parts and manufacturing equipment

Assist in development of raw material, production material and product specifications

Summarize experimental data and draw conclusions.

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

Active participation with corrective action / preventive action projects in accordance with QuidelOrtho's Quality Management System.

Assist in maintaining the Quality Management System

Maintain a safe working environment.

Performs additional work related duties as assigned.

The Individual Required Skills:

BA/BS in Scientific field required

Must have experience as a Quality Engineer: 5+ years

Must have experience as a Quality Engineer on new product development: 3+ years

Must have experience working and managing time lines/deliverables.

New product development design control processes

Project planning

Strong analytical and problem solving skills

Good organizational skills, and the ability to manage multiple tasks

Experience in experimental design

Ability to work within cross functional teams

Strong communication skills, written and verbal

Must exhibit professionalism, confidence, maturity, desire to succeed and be proactive/ self-motivated

Strong knowledge of relevant Quality and analytical tools

Ability to participate in planning and managing project deliverables

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

Knowledge of related quality systems regulations and processes

Appropriate computer skills (e-mail, word processing, statistical, spreadsheet and graphing software)

Preferred:

QE certification

The Key Working Relationships Internal: R&D, Engineering, Quality, Operations and Regulatory, Supplier Quality Engineers, Process Engineers and Manufacturing Quality Engineers

External: Vendors and contractors

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

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

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.

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 $78,600.00 - 145,000.00. 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 Employer

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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