Summary:

Provides quality engineering support during new business development, new program launches and for existing customer programs

Essential Duties and Responsibilities:

Support new business development Provides support to new business development relating to quality matters as needed Draft preliminary Quality Plan, if appropriate Provides cost and time estimates for anticipated quality department services such as metrology or validation services Functions as a resource for applicable ISO Program and QSR Program requirements Support Program Launch and Product Realization as functional department representative assigned to team and Program Manager Reviews new program drawings/information/customer specifications to understand program requirements Determines quality and reliability standards and ensures dimensional and cosmetic requirements, as well as customer specifications, are defined and understood. Drafts program Quality Plan (as required) and metrology labor plan to include definition of required fixtures, calibration and metrology requirements and measurement methods needed to meet customer requirements for approval Drafts other required quality documentation such as Dimensional Visual Quality Requirements (DVQR's) and new product inspection techniques Confirms customer agreement on GD&T callouts/interpretations and all critical dimensions of program when required Prepares Failure Mode Effects Analysis (FMEA), as needed Prepares Traveler Document Develops required Control/Test methods Ensures First Article Inspection (FAI) and Capability Studies are scheduled and completed Completes FAI and capability study analysis for submission to customer Authors operational qualification (OQ) and performance qualification (PQ) protocols and provides training for protocol participants Oversees the execution of assigned OQ and PQ studies to ensure compliance with protocol requirements and completion of study tasks Authors OQ and PQ Completion Reports to include resolution of any deviations recorded and overall study conclusion Establishes \"golden sample\" standards and prepares and submits to customer via customer approval form (CAF) as required Attends program team meetings to address quality-related matters Performs assigned activities in a timely manner Provide continuous quality engineering support through program end of life. Completes Certificates of Conformance (CoC) for outgoing products, where required Collects and analyzes production line data to monitor yield and defect performance Ensures golden samples are retained and controlled Maintains Device History Records (DHR) as necessary Performs periodic risk assessments, as required Assists Purchasing Department with maintaining vendor quality requirements Continuously monitors production to identify quality-related customer issues and supports corrective action plans when necessary Issue or authorize CCR's as needed. Manages the return of goods, assignments and close out of RC/CA. Conducts root cause investigation and develops corrective action plans for assigned problem reports (PSRs) and quality issues Manages product and process change control and notification to ensure required Engineering Change Orders (ECOs) are generated and approved by the customer prior to implementation. Attends program team meetings as necessary to resolve program quality issues to maintain customer satisfaction Support QBR's with customer and provides/presents quality-related topics Participates in customer, certified body, and regulatory audits as a subject matter expert for assigned products and processes Occasional domestic travel required Has a working knowledge of Statistical techniques and sampling plans and of Quality Systems Regulations and ISO Standards Other duties as assigned

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience:

High school diploma with five years related experience, Associate's degree (A. A.) or equivalent from two-year college or technical school with three years related experience, or Bachelor's degree (B.S.) in a technical (STEM or Engineering) field, with zero to one year related experience. Experience in a 21CFR Part 820 or

ISO 13485

quality system environment strongly preferred. 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