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 Staff Design Quality Engineer. Responsible to ensure that QuidelOrtho products are developed in compliance with QuidelOrtho Product Delivery & Quality Systems, and worldwide Design Control Regulations, and that subsequent Lifecycle design change controls are effective.

　　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. Interface with global manufacturing facilities and external partners for technology transfer of new products and maintenance of Lifecycle design quality.

　　Identifies benchmarks for improved performance and participates in policy/procedure/ guideline development, including incorporation of relevant information into QuidelOrtho programs. May include comprehensive reviews of historical documentation, processes, validations, and training programs.

　　Collaborates to plan and organize projects aimed at exploring and solving unique problems, including special requests for comprehensive investigations of product designs.

　　Provides compliance support for internal and external audits, including support of audit preparation, as well as support for investigations and corrective actions stemming from audit observations as required.

　　The position can be located in Rochester, NY or Raritan, NJ.

　　The Responsibilities

　　Provides Design Control/ Design Change Control Guidance to product development teams including risk management and support of regulatory strategies and plans.Ensure effective partnering and collaboration with R&D, Quality Operations peers, Regulatory and Operations to meet project goals, maintain compliance, and complete defined regulatory submissions.Ensures effective implementation of risk management requirements to prevent unanticipated failure modes and quality issues.Works with limited management oversight and sets an example in ensuring compliance to Design Controls and other Quality System requirements to assigned project(s).Ensures that DQ, Design Transfer processes, standards, tools and techniques effectively and efficiently meet external standards. Leads process improvements in this area.Collaborates with other QRC groups, R&D and Operations to ensure successful Regulatory Inspections.Collaborates with partner Quidel organizations in projects aimed at exploring and solving unique problems, including special requests for comprehensive investigations of product designs.Participates in post launch failure investigations.Supports integration of design control systems, DHF information for products acquired by QuidelOrtho.Utilizes advanced Quality Engineering tools (data analysis, statistics, sampling plans, etc.) to ensure effective product development.Leads in identifying benchmarks for improved performance.Suppliers/External Manufacturers: Directly or indirectly support design change control activities.Provides training, guidance and leadership to junior members of the team.Performs other work-related duties as assigned.

　　The Individual

　　Required:

　　Bachelor of Arts / Bachelor of Science in Life Sciences, Engineering, or Physical Science required OR 8+ years equivalent experience in technical and/or quality systems with BA/BS in a related field. Master of Arts /Master of Science in Life Sciences, Engineering, or Physical Science preferred.A minimum of 7 years of experience with BS in Life Sciences, Engineering, or Physical Sciences, or 5 years of experience with MS in these fields with a strong preference for experience in a functional Quality role.Experience in handling external and internal regulatory inspections.Experience in product performance validation.Understanding/training in FDA CFR Part 820, Part 11, and ISO 13485 regulations.Advanced oral and written communication skills, including the ability to write technical reports and presentations.Computer skills/data analysis skills (Example: Word, Excel, PowerPoint, Minitab, Visio, and MS Project).

　　Preferred:

　　Experience as a quality engineer, including risk management/risk-based analysis, nonconformance, root cause investigation and corrective/preventive action is preferred. Experience in FMEA or FTA is preferred.ASQ CQE/CQA certification a plus.Strong project management skills.Process Excellence Black Belt or Green Belt with strong problem solving skills.

　　The Key Working Relationships

　　Internal Partners:

　　R&D/Product Lifecycle: QA Partners for New Product Development/Lifecycle Product Design Change.Regulatory Affairs: Integrating current Regulatory expectations into Design Control/Design Change Control processes; facilitating content development for regulatory submissions.Operations Quality: Effective technology transfer of quality elements related to new product introduction; partnership for process changes that result in design change.Post Market Risk Management: Shared accountability for Product Risk management lifecycle; Integrating Post-market surveillance lessons learned/CAPA into product development processes.

　　External Partners:

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

　　The Work Environment

　　Typical office environment with data management. No strenuous physical activity, though occasional light lifting of files and related materials is required. 40% of time in meetings, working with team, or talking on the phone, 60% of the time at the desk on computer, doing analytical/ development work. Occasional travel may be required. Flexible work hours to meet project deadlines.

　　Salary Transparency

　　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 that facts and circumstances of each case. Salary range for this position is $80,000 to $143,000 and 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 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 .

　　#LI-JP1

　　Equal employment opportunities for all employees. We fulfills this commitment through a variety of measures including internal & external posting of job openings, hiring, training & promoting individuals without regard to race, color, religion, sex, p regnancy, national origin, ancestry, citizenship, veteran status, disability, medical condition, marital or domestic partner status, sexual orientation, gender identity, age,or any other considerations made unlawful by federal,state or local law