Operations Quality Engineer

2nd shift : 3 : 30 PM-2 : 00 AM Monday, Tuesday, Wednesday, Thursday, flex Friday as needed

• This would be a singular Operations Quality Engineer, supporting our second shift.
• This would be a universal player conducting Quality Engineering based work.
• Their day to day will likely vary, depending on what is going on in the manufacturing space and business needs.
• They will own NCs and potentially CAPAs, needing to bring in cross functional teams, driving with urgency to resolve the issue.
• They will contain nonconforming product and work with the Operations team when a line down situation occurs, which is a fast-paced environment.
• They will also work with Operations to ensure quality performances of products and processes.
• They will own PPAPs and SICRs (Supplier Initiated Change Request), for supplier changes, which can be an urgent change or ones that are less urgent.
• They may also be brought into process improvements / validation reviews for internal efforts.

Key Areas of Responsibility :

o Collaborate with Internal cross-functional and Supplier teams to address top quality issues.

o Own identified internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventative Action records (CAPA), managing the timely processing and closure of NC and CAPA records within the electronic management system, Trackwise.o Support execution and analysis of manufacturing related complaint investigations o Investigate and disposition internal non-conforming product within MRB, issuing NCs as appropriate.

o Communicate & collaborate with suppliers regarding non-conformances, escalating Supplier Corrective Action Requests (SCAR) as required.

o Execute and manage Supplier Initiated Change Requests (SICRs) received from suppliers, engaging with cross-function teams for assessment and approval

o Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification.

o Engage in the development and improvement of the internal manufacturing and distribution processes for existing products.

o Perform critical assessments and qualifications of internal and supplier-proposed change management activities, including Production Part Approval Process (PPAP) activities for supplier changes.

o Participate in and potentially lead the creation and / or review of new or modified procedures.

o Support the development and review of process and equipment validation / qualification and MSA of internal processes.

o Maintain KPIs for monitoring of process and / or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.