Quality Engineer

QuidelOrtho-posted 3 months ago
$79,000 - $110,000/Yr
Full-time • Mid Level
Carlsbad, CA
5,001-10,000 employees
Chemical Manufacturing
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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.

  • Process Flow Diagrams and Control Plans.
  • Review, revision, and maintenance of FMEA/ Risk Analyses.
  • Validations.
  • Generation of protocols and support for creating validation protocols.
  • Generation of master validation plans for manufacturing processes and product improvements.
  • Work with Engineering to validate process components.
  • Work with Engineering to develop test methods.
  • Sampling plans.
  • Factory/Quality Standards to support customer complaints.
  • Provides technical support for departmental activities in significantly reducing product rejection, scrap, and variances, and improving both the quality and business systems inefficiencies.
  • Collects data for development of corrective actions.
  • Works with Manufacturing and Engineering groups to write and execute validations of process and system improvements.
  • Provides technical support for the non-conforming materials function through effective technical root cause failure analysis, material dispositioning and corrective action implementation.
  • Actively supports closed loop corrective actions through effective technical root cause failure analysis and troubleshooting investigations.
  • Reviews procedural deviations for compliance with internal quality and external regulatory requirements.
  • Ensures compliance of the validation system to quality and regulatory standards.
  • Contributes to the corporate efforts in support of the internal quality audit program and external supplier assessment.
  • Assists in the development, implementation, and monitoring of the corporate quality system functions and culture.
  • Performs duties in compliance with established business policies.
  • Perform other work-related duties as assigned.
  • B.S. in Engineering/Chemistry/Biology/Technical Discipline preferred or equivalent combination of certification and work experience.
  • 2-5 years' experience in Quality and Manufacturing Systems in Medical Device or other highly regulated industries and high-volume manufacturing environments.
  • Quality Tools - Problem Solving / Statistical Process Control / Process Capability / ISO 9001 / ISO 13485 / Design of Experiments / Sampling Plans.
  • Communication Skills - Ability to communicate effectively with all levels of employees throughout the organization.
  • Computer skills - proficient in Microsoft Office, statistical software programs, operating systems, voice, and email.
  • Project management, multiple tasking, and excellent prioritization skills.
  • Knowledge of quality systems and regulations for the medical device industry.
  • Results-oriented commitment to the continuing evolution of the quality control system within defined regulatory and corporate requirements.
  • Practical, common sense knowledge base and approach in developing, implementing, and administrating the quality control system.
  • Technically knowledgeable with respect to quality systems, regulatory standards, supplier/subcontractor management, manufacturing systems, product development, project management, material flows, and general production principles.
  • Auditing experience and certification strongly.
  • Comprehensive benefits package including medical, dental, vision, life, and disability insurance.
  • 401(k) plan.
  • Employee assistance program.
  • Employee Stock Purchase Plan.
  • Paid time off (including sick time) and paid Holidays.
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