Quality Engineer

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. Experience with Six Sigma or Lean manufacturing techniques preferred.