Senior Quality Engineer
19 hours ago
- Partner with operations to evaluate and address quality events including nonconformances, product dispositions, root cause investigations, and implement appropriate CAPA based on risk level. Properly assess risk of quality events and ensure that appropriate and timely mitigations (short and long-term) are implemented. Analyze and monitor key quality metrics and develop action plans to address unfavorable trends.
- Lead and promote continuous improvement activities by seeking out opportunities to optimize processes and systems to reduce variation and improve product quality. Drive implementation of best practices to eliminate repeat quality events and improve product quality.
- Support product and process root cause investigations by collaborating with product support, engineering, and operations.
- Support and participate in inspection readiness activities by applying working knowledge of ISO13485 and 21CFR Part 820 regulations.
- Mentor and train junior quality engineering staff in application of quality engineering principles. Provide coaching, training, and technical guidance to business partners in aspects of the company quality system requirements as they pertain to manufacturing quality and provide guidance of effectively applying key quality engineering principles and tools.The Individual
- B.S. Degree in Chemistry, Biochemistry, Biology, Engineering, or a related discipline.
- 5-7 years of experience in Quality in a highly regulated manufacturing environment (Diagnostics, Medical Device, Pharmaceutical, or Consumer).
- Advanced Microsoft Office (Word, Excel, PowerPoint, etc.) tools experience for communications, reporting and data analysis is required.Key Working Relationships
- Internal Partners: Planning, Quality Engineering and Product Support.
- External Partners: customers and vendors.The Working EnvironmentThe work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines.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. The salary range for this position is $95,000 to $105,000. 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 Employment 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
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