Senior Quality Assurance Engineer

4 weeks ago

San Diego, California, United States QuidelOrtho Full time
The Opportunity

QuidelOrtho, a world-leading in vitro diagnostics company, is seeking a Senior Supplier Quality Engineer to support Quality Operations. With a strong presence in over 130 countries, we provide fast, accurate, and consistent testing solutions where and when they are needed most.

The Role

As a Senior Supplier Quality Engineer, you will be responsible for ensuring that products, services, and materials received from suppliers meet our quality standards and regulatory requirements. This involves interacting and collaborating with suppliers to resolve quality issues, conducting supplier audits, and continuously improving supplier quality performance.

Responsibilities
  1. Evaluate suppliers for technical capability and quality system performance to onboard and maintain supplier relationships.
  2. Lead and positively influence product improvements of supplied products through effective use of our quality system.
  3. Manage nonconforming material functions through effective identification, segregation, technical root cause failure analysis, and disposition of material.
  4. Support root cause failure investigation activities and write, edit, and approve investigation reports related to suppliers.
  5. Participate in Complaint Committee meetings and present investigation findings to peers and management.
  6. Represent the Quality Control department from a supplier perspective in evaluating failures, performing technical root cause analysis, and developing and executing corrective and preventive actions.
  7. Perform statistical analysis of supplier performance data, data from experiments, and manufacturing process trend monitoring to serve as inputs into supplier performance monitoring and scorecards.
  8. Attend and actively participate in Management Review Board and present findings and recommendations.
Requirements
  • B.S. in Engineering, Chemistry, Biology, or Technical Discipline or equivalent combination of certification and work experience.
  • 3-5 years' experience in Quality and Manufacturing Systems.
  • Problem Solving Methodologies, Process Capability, ISO 13485, Design of Experiments, and Sampling Plans.
  • Supplier Quality skills and experience, including qualification, auditing, performance management, and SCAR management.
  • Leadership experience in technical teams and problem-solving methodologies.
  • Strong technical aptitude and experience, with high-level technical writing skills and ability.
  • Excellent communication and interpersonal skills.
  • Ability to communicate effectively with all levels of employees and develop strong working relationships with internal and external customers.
  • Experience interacting with Regulatory Bodies (FDA, ISO) is preferred.
Work Environment

The work environment is a combination of office, laboratory, and manufacturing settings. Flexible work hours are available to meet project deadlines, and occasional travel is required up to 10% of the time.

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