- Partner with operations to evaluate and address quality events including nonconformances, product dispositions, customer complaints, root cause investigations, and implement appropriate corrections and/or corrective actions 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 and control variation.
- 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.
- Conduct product risk assessments and manage Product Risk Files (i.e. FMEA's).
- Support change control process.
- 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 such as performing design of experiments, gage R&R, and process capability assessments.
- Performs other work-related duties as assigned.
- B.S. Degree in Chemistry, Biochemistry, Biology, Engineering, or a related discipline.
- Advanced Microsoft Office (Word, Excel, PowerPoint, etc.) and other statistical software tools (e.g. MiniTab).
- Experience with establishing sample plans, quality test plans, and summarizing / reporting data analysis, is required.
- 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.
- 1-3 years of experience in Quality in a highly regulated manufacturing environment (Diagnostics, Medical Device, Pharmaceutical, or Consumer).
- Knowledge of current and applicable GMP regulations including ISO13485 and 21 CFR Part 820.
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Quality Engineer - Athens, United States - QuidelOrtho
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 6,000 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
The Quality Engineer provides support to Quality and Operations on all aspects of the manufacturing process. The position will work to resolve quality issues by ensuring adequate root cause investigations conducted and verifying effectiveness of CAPAs implemented. The position 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 QuidelOrtho's Quality Policy. The position will assess risk and will drive quality related decisions.
This role is located in Athens, Ohio.
The Responsibilities
The Individual
Required:
Preferred:
The Key Working Relationships
Internal Partners:
Operations, Engineering, Product Support, Laboratory Personnel, Regulatory Affairs, and Compliance and Regulatory Agencies.
The Work Environment
The work environment characteristics are representative of both an office and manufacturing environment. Flexible work hours to meet project deadlines. Occasional travel maybe required. Travel includes airplane, automobile travel and overnight hotel.
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
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