Analysis Skills, Biology, Business Administration, Coaching, Code of Federal Regulations, Communication Skills, Continuous Improvement, Cross-Functional, FDA (Food and Drug Administration), Hardware Design, ISO (International Organization for Standardization), Lean Six Sigma, Maintain Compliance, Manufacturing Requirements, Medical Equipment, Problem Solving Skills, Process Improvement, Product Design, Product Lifecycle, Project Management Professional (PMP), Quality Assurance, Quality Engineering, Quality Management, Regulations, Regulatory Compliance, Regulatory Requirements, Research & Development (R&D), Technical Leadership, Technical Support, Technical/Engineering Design, Time Management
Rochester, NY or San Diego, CA, NY
Join Our Team as a Senior Design Quality Engineer
Are you passionate about ensuring top-notch quality in product design and development? Join QuidelOrtho's Global Quality & Compliance (GQ&C) team as a Senior Design Quality Engineer. This role is based in the vibrant locations of Rochester, NY, or San Diego, CA, offering you the opportunity to work in dynamic environments that foster innovation and growth.
About the Role
As a Senior Design Quality Engineer, you will play a critical role in providing technical support and oversight of Quality systems, processes, and programs. You will ensure compliance with global regulatory requirements and drive continuous improvement initiatives. Collaborate with cross-functional teams to integrate Quality and Compliance principles throughout the product lifecycle and contribute to a culture of scientific excellence and high performance.
Key Responsibilities
- Support complex Quality engineering activities ensuring timely delivery and high technical rigor.
- Apply technical, regulatory, and Quality systems knowledge to ensure compliance with ISO 13485, FDA 21 CFR 820, IVDR, and other applicable standards.
- Collaborate closely with R&D, Regulatory Affairs, Manufacturing, and other stakeholders.
- Drive continuous improvement initiatives within the Quality Management System (QMS).
- Provide coaching and technical guidance to peers and project teams.
Requirements
- Bachelor's degree in Life Sciences, Engineering, or a related technical discipline.
- 5 years of progressive experience in Quality, Compliance, or related fields.
- Strong understanding of Quality System regulations and standards.
- Excellent collaboration, influence, and communication skills.
- Strong analytical and problem-solving skills.
Preferences
- Advanced degree (MS, PhD, MBA, or equivalent).
- Experience implementing or optimizing global Quality Management Systems (QMS).
- Lean Six Sigma, PMP, or similar certification.
- Experience supporting or leading Health Authority or Notified Body inspections.
Ready to make an impact? Apply now and be part of a team committed to quality excellence and innovation. Join us in Rochester, NY, or San Diego, CA, and contribute to meaningful outcomes in the Medical Device, IVD, and Biopharmaceutical industries.
Subject Line: Senior Design Quality Engineer Opportunity at QuidelOrtho
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