Staff Quality Assurance Engineer
3 days ago
QuidelOrtho, a world-leading in vitro diagnostics company, is seeking a Staff Quality Engineer to support our complex quality engineering activities. This role will monitor and measure compliance with the Quality System Regulation, Quality policies, FDA and ISO regulations, as well as product quality and compliance objectives.
The Responsibilities- Participate in complex design transfer, design control, and improvement projects.
- Review and audit highly complex records, testing plans, and risk analysis.
- Conduct quality training, provide coaching, and guidance.
- Set strategic direction for addressing compliance issues.
- Identify improvement opportunities and lead complex, cross-functional projects.
- Perform root cause analysis of complex product quality issues.
- Perform failure mode analysis on new or existing products and develop mitigations.
- Develop verification and validation plans for new products and processes.
- Support the change control process, including risk assessments and verification and validation.
- Support the Non-Conformance and CAPA processes.
- Carry out duties in compliance with established business policies.
- Assist and/or lead audit readiness activities.
- Bachelor's degree in Engineering, Chemistry, Biology, or Medical Technology, or equivalent combination of certification and work experience.
- Master's degree in Engineering, Chemistry, Biology, or Medical Technology, or equivalent preferred.
- Minimum of 7 years of related experience in quality or engineering, with medical device/diagnostics experience preferred.
- Experience with root cause analysis, failure mode analysis, verification, and validation.
- Statistical tools, including basic statistical inference, graphical methods, and statistical sampling.
- ASQ certification and/or six sigma certification preferred.
- Analytical and problem-solving skills, including statistical and risk analysis.
- Advanced skills in Microsoft Office and statistical software programs.
- Strong written and verbal communication skills.
- Working knowledge of FDA regulations.
- Manufacturing quality experience in a medical device, biologics, pharmaceutical, or similar FDA-regulated environment.
- Internal partners: all levels of the organization.
- External partners: customers and vendors.
The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment. The role requires handling of viral and bacterial hazards, potentially hazardous chemicals, and infectious or potentially infectious bodily fluids, tissues, and samples.
The Physical DemandsThe role requires up to 75% of time at desk, standing, or sitting for extended periods. Specific vision abilities are required, including close and distance vision and the ability to adjust focus.
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