Senior Design 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 Design Quality Engineer supporting our instrument or assay lifecycle development. The Design Quality Engineer (DQE) is responsible to ensure that QuidelOrtho products are developed in

compliance with QuidelOrtho product delivery procedures, QuidelOrtho Quality Management Systems, and worldwide Design Control Regulations, and that subsequent lifecycle design change controls are effective. The DQE provides direction to Design and Development teams and is responsible for ensuring completion of key design control outputs which include, but are not limited to, documentation to support efficient worldwide regulatory submissions, product risk management documentation, and comprehensive design history.  The DQE is required to interface with global manufacturing facilities and external partners for technology transfer of new products and maintenance of lifecycle design quality.  The DQE provides compliance support for internal and external audits, including support of audit preparation.  The DQE provides support for or leads investigations and CAPA (corrective actions / preventive actions) as required.

This position will be onsite working a hybrid schedule (2-3 days onsite) – open to San Diego, CA or Rochester, NY offices.

The Position

• Supports new product development and maintains commercial products
• Develops and maintains Risk Management File (e.g. RM Plans, RM Reports, FMEAs, FTA, Hazard Analysis)
• Performs Risk Assessments for design and/or process changes
• Administers Master Validation Plans (MVP)
• Works with new product design trees
• Generates Change Orders as required to support New Product Development or commercial product
• Assists in the development of Design Trace Matrices
• Reviews validation reports and other technical documentation
• Determines experimental sampling plans
• 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
• Mentors Quality Assurance Engineering staff
• Carries out other duties, as required, in compliance with established business policies
• Performs other work-related duties as assigned

The Individual

Required:

• BA/BS in Scientific field required or equivalent experience and a minimum 5 years Quality Engineering experience in a medical device or equivalent regulated environment, 3 of those years of experience in new product development
• A minimum of 3 years of experience with Risk Management (e.g., EN ISO 14971) principles
• Demonstrated Project planning skills required
• Strong analytical and problem-solving skills required
• Good organizational skills, and the ability to manage multiple tasks required
• Experience with project management
• Ability to work within cross functional teams
• Strong communication skills, written and verbal
• Professionalism, confidence, maturity, and self-motivation
• Strong demonstrated application of relevant Quality and analytical tools
• Advanced knowledge of manufacturing tools and processes (e.g. BOM, Routings, SPC Charts, Risk Management, Quality Test Plans and Master validation plans)
• Advanced knowledge of related quality systems regulations and processes required
• Computer skills (e-mail, word processing, statistical, spreadsheet and graphing software)
• Ability to make decisions and build consensus across QA team and internal and external stakeholders 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
• Ability to travel up to 10% domestically and internationally
• This position is not currently eligible for visa sponsorship. 

Preferred:

• QE Certification
• Experience in experimental design
• Process Excellence Black Belt or Green Belt with strong problem-solving skills
• Experience working with instrument software or assay development

The Key Stakeholders

Internal Partners:

• R&D/Product Support – New product and lifecycle management (LCM) – Primary business partner for new product and LCM projects.
• Project/Program Management - Business partner for new product and LCM projects.
• Regulatory Affairs – Partner to integrate current regulatory expectations into Design Control/ Design Change control processes – facilitate content development for submissions.
• Operations/Engineering/Operations Quality – Partner for effective design transfer to internal and external partner locations for new development and design change.
• Post Market Risk Management - Shared accountability for Product Risk management lifecycle; Integrating Post-market surveillance lessons learned/CAPA into product development processes. Management - Provide updates regarding projects.

External Partners:

• Suppliers/ External Manufacturers: Directly or indirectly support design transfer and design change control activities.
• External Development Service Providers: Define accountabilities between companies for Design Control elements on a project by project basis, monitor quality activities and project deliverables for adherence to regulatory requirements.

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 $90,000 to $125,000 depending on location of hire (San Diego, CA or Rochester, NY) and this role is bonus eligible. 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].