QuidelOrtho is seeking a Senior Quality Engineer to provide Quality oversight of the manufacturing of in vitro diagnostic medical devices, resolve quality issues, and optimize processes to improve quality and cost, aligning with business goals and the company's Quality Policy.
Requirements
- 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.
- 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.
Responsibilities
- Partners with Operations to evaluate and address supplier related quality events including non-conformances, product dispositions customer complaints, root cause investigations and implement appropriate corrections and/or corrective actions based on risk level.
- Analyzes and monitor key quality metrics and develop action plans to address unfavorable trends.
- Oversees site specific supplier quality activities such as review/approval related to additions/updates to the approved supplier list, evaluation of supplier related non-conformances for Supplier CAPA eligibility, management of Supplier CAPA, evaluation of supplier change notifications for product impact and providing supplier audit support.
- 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
Other
- Bachelor of Science degree in Engineering, Science or related field of study and minimum 5-yrs experience or equivalent combination of experience and education.
- 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.
- American Society of Quality (ASQ) Certification
