Position Purpose: Proactively build quality into the process, by understanding the Voice of the Customer and translating those requirements into documented information. Qualify new, and changes to existing, manufacturing processes. Drive Continual Improvement by facilitating interdepartmental problem solving throughout the business. Essential Duties: Utilize documented information (provided by the customer) to understand the Voice of the Customer, and effectively communicate these requirements to responsible parties during the Quotation process. Create new, and update existing, master production work instructions (i.e. OQRs, Pack Cards, etc). [For contract manufacturing] In accordance with the customer provided DFMEA, lead the cross-functional team to create and update the associated PFMEA for the production process. [For products that Flambeau is Design responsible for] Provide input/work with the team to develop the DFMEA. In accordance with the DFMEA, create and update the associated PFMEA for the production process. In accordance with the PFMEA, create and update the associated Control Plan for the product. [Whether for contract manufacturing or Design responsible products] In accordance with the PFMEA, create and update the associated Control Plan by properly identifying the Critical Control Points in the process. Generate and approve applicable Deviations and Waivers. Investigate and provide disposition (approve/deny) for potential external failures (i.e. Customer Complaints & Warranty Claims). Conduct required Risk Assessments associated with internal (NCs/MRBs) and/or external failures (Customer Complaints) to determine if product can be used as is, can be reworked/sorted, or must be scrapped. Based on the risk assessment, if the product can be reworked/sorted, provide guidance on the rework Plan phase (of PDCA). Conduct the Bracketing Rationale using data/evidence to support the Containment plan for external (i.e. Customer Complaints) failures. Construct the timeline of production (i.e. the story of how it happened, not why it happened) for confirmed external failures (i.e. Customer Complaints), to feed into Root Cause Analysis. If a Confirmed Complaint (if applicable), issue a Return Material Authorization (RMA) to the customer. Facilitate the cross-functional investigation to determine Root Cause of Internal (i.e. NCs/MRBs) and External failures (i.e. Customer Complaints). Facilitate the cross-functional Brainstorming of Action Items to specifically address the identified Root Cause. Qualify new, and changes to existing, manufacturing processes (i.e. which may involve PPAP submissions for Automotive customers). Generating new, and updating existing, Standard Operating Procedures (SOPs) Assisting with External Audits (i.e. customer, regulatory, etc), as necessary. Effectively communicate and build relationships with customers to facilitate resolution of quality issues. Visit customers as needed to maintain relationships and resolve issues. All other duties assigned by Manager