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The OpportunityQuidelOrtho 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 RoleAs we continue to grow as QuidelOrtho, we are seeking a Design Quality Senior Engineer for Immunohematology and Transfusion Medicine to support the Pencoed, UK, Pompano Beach, FL and Raritan, NJ locations. The DQE is responsible for ensuring that QuidelOrtho Immunohematology/Transfusion Medicine products are developed in compliance with QuidelOrtho Quality Systems, QuidelOrtho Product Delivery and Design Control procedures, and worldwide Design Control Regulations, and that lifecycle management design change controls are effective. The DQE is responsible for ensuring completion of key design control deliverables 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 development and technology transfer of new products and maintenance of lifecycle design quality for existing products.The DQE provides compliance support for internal and external audits, including support of audit preparation, as well as support for investigations and corrective actions stemming from inquiries and from audit observations as required.This is a remote role, but the individual must be in commuting range of one of the following QuidelOrtho locations: Rochester, NY, Raritan, NJ, or Pompano Beach, FL.The ResponsibilitiesUnder guidance of management and more senior design quality engineers:Provides Design Control/ Design Change Control Guidance to product development teamsSupports effective partnering and collaboration with R&D, Quality Operations, Regulatory, Operations and External Business Partners to meet project goals, maintain compliance, and complete defined regulatory submissions.Supports effective implementation of risk management requirements to prevent unanticipated failure modes and quality issues.Works with management oversight and sets an example in ensuring compliance to Design Controls and other Quality System requirements to assigned project(s).Supports efforts to ensure that Product Development, Design Control and Design Transfer processes, standards, tools and techniques effectively and efficiently meet external standards and supports process improvements.Collaborates with other Quality/Regulatory/Compliance groups, R&D and Operations to ensure successful regulatory inspections/audits.Provides Quality oversight for product- and/or process-related nonconformances/root cause investigations/ Corrective and Preventive Actions.Participates in post-launch failure investigations and risk management activities as requested.Supports integration of design control systems and DHF information for products within QuidelOrtho and for products acquired by QuidelOrtho.Utilizes advanced Quality Engineering tools with guidance (data analysis, statistics, sampling plans, etc.) to ensure effective product development.Identifies benchmarks for improved performance.Works with suppliers/external manufacturers to directly or indirectly support design change control activities under guidance.Performs other duties & projects as assigned.The IndividualBachelor's Degree in Life Sciences, Engineering, Physical Science or related field, with a minimum of 3 years of related experience preferably in Blood Banking. Desirable related knowledge includes experience in the use of QuidelOrtho products and systems (Vision, Workstation, AutoVue, BioVue). Desirable certifications include ASQ -CQA, ASQ-CQE, ASQ-SWQE, ASQ-CQM, Computer skills/data analysis skills (Word, Excel, PowerPoint, Minitab, Visio, and MS Project) required. Effective oral & written communication skills required. Comfortable with up to 10% Domestic & International travel (WW locations for direct reports; interactions with Suppliers/Development Business partners).Key Working RelationshipsInternal: R&D - new product and LCM - primary business partner for new product and LCM projectsRegulatory Affairs - integrate current regulatory expectations into Design Control/ Design Change control processes - facilitate content development for submissions.Operations Quality - effective design transfer to internal and external partner locations for new development and design changes.Post Market Risk Management - shared accountability for Product Risk management lifecycle; Integrating Post-market surveillance lessons learned/CAPA into product development processes.External: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 QA activities and project deliverables for adherence to regulatory requirements.The Work EnvironmentCombination of operations and desk environment.The DQE must be located within commuting range of QuidelOrtho location in Raritan, NJ.Up to 10% domestic and international travel.Salary TransparencyThe 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 $65,000 to $118,000 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 OpportunityQuidelOrtho 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 recruiting@quidelortho.com.#LI-AK1Equal 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
