Quality Engineer

This job was posted by https://www.vermontjoblink.com : For more information, please see: https://www.vermontjoblink.com/jobs/1408816 **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 ```{=html}

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• 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 (DVQRs) 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 ```{=html}

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• 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 CCRs 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 QBRs 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 ```{=html}

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• 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. Experience