QuidelOrtho · 12 hours ago
Quality Engineer II
US - FL - Pompano Beach
Full-time
Onsite
Entry, Mid Level
$95K/yr - $115K/yr
2+ years expQuidelOrtho is a world-leading in vitro diagnostics company resulting from the unification of Quidel Corporation and Ortho Clinical Diagnostics. They are seeking a Quality Engineer II focused on quality oversight of manufacturing in vitro diagnostic medical devices, driving quality-related decisions and ensuring compliance with regulatory requirements.
Medical Device
Responsibilities
Partner with operations to evaluate and address quality events including nonconformances, customer complaints, root cause investigations, and implement appropriate corrections and/or corrective actions based on risk level
Dispositions raw materials and products in accordance with defined procedure and/or utilizing a risk-based approach
Performs containment activities as needed
Participates in validation and /or qualification procedures and technical reports associated with both process validation and equipment qualification activities
Provides Quality oversight, review and approval of Change Control activities
Demonstrates problem solving skills. Identifies and resolves problems in a timely manner. Gathers and analyzes information skillfully. Develops alternative solutions effectively. Analyzes technical data and proposals
May promote or participate in continuous improvement activities by seeking out opportunities to optimize processes and systems to reduce and control variation
Support product and process root cause investigations by leading, facilitating, and collaborating with product support, engineering, and operations
Support and participate in inspection readiness activities by applying working knowledge of ISO13485, 21CFR Part 820 and IVDR regulations
Conduct product risk assessments and initiate/update Product Risk Files (i.e. FMEA’s)
Collaborate with R&D on design transfer activities / plans, that may include, but are not limited to the development of raw material specifications, process controls, and validation
Utilize quality engineering tools and problem-solving techniques to support QO Improvement culture
May author and/or update standard operating procedures, technical reports and validation documentation
Perform other work-related duties as assigned
Qualification
Required
Bachelor of Science degree in Engineering, Science or related field of study and minimum 2-yrs experience or equivalent combination of experience and education
Intermediate Microsoft Office (Word, Excel, PowerPoint, etc.) and statistical tools (e.g. Minitab)
Experience with establishing sample plans, quality test plans, and summarizing / reporting data analysis
Clearly and effectively documents, communicates, and presents technical information
Works effectively independently as well with a cross-functional team across Operations, Product Support, Compliance, Regulatory, and Suppliers
Demonstrates a high degree of accuracy and attention to details
Strong organization and time management skills
Analytical and problem-solving skills with an ability to use scientific knowledge and statistical methods to identify and resolve issues
Knowledge of current and applicable regulations including ISO13485, 21 CFR Part 820, and IVDR or equivalent experience
Preferred
American Society of Quality (ASQ) Certification
Benefits
Medical
Dental
Vision
Life
Disability insurance
401(k) plan
Employee assistance program
Employee Stock Purchase Plan
Paid time off (including sick time)
Paid Holidays
Company
QuidelOrtho
> Bringing precision and passion in everything we do QuidelOrtho stands at the forefront of testing, tracking and disease analysis of health conditions ranging from HIV and hepatitis C to flu, strep and COVID-19.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Joe Busky, CPA
Chief Financial Officer
Michael Iskra
Executive Vice President and Chief Commercial Officer
Recent News
2025-12-18
2025-11-06
2025-11-06
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