Quality Engineer II
Quality Engineer II
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Job Description
The Opportunity
QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing clinical chemistry and transfusion medicine. We are more than 6000 strong and do business in over 130 countries providing answers with fast accurate and consistent testing where and when they are needed most home to hospital lab to clinic.
Our culture puts our team members first and prioritizes actions that support happiness inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.
The Role
As we continue to grow as QuidelOrtho we are seeking a Quality Engineer II. The Quality Engineer II will provide quality engineering support to Quality and Operations staff on all aspects of the manufacturing process at the Rochester Manufacturing Site. The candidate will work to resolve nonconformances by ensuring adequate RCIs are conducted and effective CAPAs are implemented. The candidate will utilize key Quality Engineering principles tools and practices to develop and optimize process controls and quality system processes and identify opportunities to improve quality and cost that are aligned with the overall business goals and Orthos Quality Policy. The candidate will accurately assess risk and will drive quality related decisions.
This opportunity is located in Rochester NY.
Responsibilities
Partner with operations to evaluate and address quality events including nonconformances product dispositions root cause investigations and implement appropriate CAPA based on risk level.
Analyze and monitor key quality metrics and develop action plans to address unfavorable trends.
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.
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.
Perform other work-related duties as assigned
Required:
B.S. Degree in Chemistry Biochemistry Biology Engineering or a related discipline.
3-5 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.
Preferred:
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 GMP regulations including ISO13485 and 21 CFR Part 820
Key Working Relationships
Internal Partners: Operations Engineering Product Support Laboratory Personnel Regulatory Affairs and Compliance
External Partners: Regulatory Agencies
Work Environment
The 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. Working around moving machinery. Protective equipment required as needed.
Salary Transparency
The 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. At QuidelOrtho it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range is $68000.00 to $116000.00 and is bonus eligible. 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 Opportunity
QuidelOrtho 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 r.
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Employment Type
Full-Time
