Key Areas of Responsibility :

• Work closely with Operations and the business functions to ensure quality performance of product and processes.

Non-Conformances :

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 and product field actions.

o Investigate and disposition internal non-conforming product within MRB, issuing NCs as appropriate.

Supplier Activities :

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 Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.

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

Additional Job Details :

• Bachelor’s degree in an Engineering/Science/technical field or a related field.
• Top 3 skills? Multi-tasking, strong communication, problem solving
• Can you give us an overview of the project this resource would be working on and what the day-to-day activities would look like? This isn’t an ask to support a project.
• 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, 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.