Quality Engineer II
- Provide guidance and Quality oversight to ensure establishment and execution of sustaining programs aligned with regulatory requirements and industry standards.
- Work with Manufacturing operations to implement plant driven changes and provide overall support of process improvements by working with engineering teams to implement process improvements to improve Quality, conducting quality improvement projects through various CI initiatives.
- Develop or update in-process inspection requirements to ensure the greatest value in process control for the customer and the plant during the manufacturing process while meeting regulatory requirements
- Provide assistance in such areas as process/equipment validation, process and product acceptance, audit correction actions, Change Control issuance for process changes.
- Manages completion of assigned complaint investigation files and works with the manufacturing site or suppliers where necessary, to complete the investigation within a timely fashion.
- Support CAPAs as owner or as part of the support team
- Monitor quality data from complaints process, Manufacturing reports, Service reports and customer input. Identifies, investigates, troubleshoots and resolves identified quality issues independently or by working with Manufacturing, Service, Engineering, Regulatory and Biostatics.
- Work to implement document changes in support of ongoing efforts to simplify internal quality procedures in alignment with business unit and corporate requirements.
- Leading investigations for quality issues resulting in yield issues by using applicable problem solving and root cause techniques.
- Complete training to support Manufacturing Quality for day-to-day operations including assuring product release, manufacturing quality training and Material Review Board (MRB) activities.
- Lead or participate in Risk Management activities appropriate to the initiative or situation.
- Lead situation analysis and support activities relating to Field Corrective Actions, when needed.
- Work collaboratively and cross functionally to improve product performance. Utilize trouble shooting and problem solving skills to identify and eliminate issues that negatively impact product performance
- Bachelor’s degree in Engineering or Science is required.
- A minimum of 3 years of experience Quality manufacturing experience
- A minimum of 3 years of experience working in an FDA or ISO regulated environment/GMP/Medical device manufacturing.
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