Quality Engineer

Mack Molding•Arlington, VT

37d•$70,000•Onsite

About The Position

Provides quality engineering support during new business development, new program launches and for existing customer programs. This role involves supporting new business development, program launches, and ongoing product realization. The Quality Engineer will act as a functional department representative on teams, review program documentation, determine quality and reliability standards, and ensure all requirements are met. Responsibilities include drafting quality plans, metrology plans, and various quality documentation, as well as preparing FMEA, Traveler Documents, and Control/Test methods. The role also involves ensuring First Article Inspections (FAI) and Capability Studies are completed and analyzed, authoring and overseeing OQ/PQ protocols and reports, and establishing golden sample standards. Continuous support through the program end of life includes completing Certificates of Conformance, analyzing production data, maintaining Device History Records, and performing risk assessments. The position also assists the Purchasing Department with vendor quality requirements, monitors production for quality issues, conducts root cause investigations, and manages product and process change control. The Quality Engineer will participate in customer meetings, audits, and provide quality-related topics for QBRs. Occasional domestic travel is required. A working knowledge of statistical techniques, sampling plans, Quality Systems Regulations, and ISO Standards is necessary. Other duties as assigned.

Requirements

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
Bachelor's degree (B.S.) in a technical (STEM or Engineering) field, with zero to one year related experience
Ability to perform each essential duty satisfactorily
Working knowledge of Statistical techniques and sampling plans
Working knowledge of Quality Systems Regulations and ISO Standards

Nice To Haves

Experience in a 21CFR Part 820 or ISO 13485 quality system environment strongly preferred
Experience with Six Sigma or Lean manufacturing techniques preferred

Responsibilities

Support new business development relating to quality matters.
Draft preliminary Quality Plan, if appropriate.
Provide cost and time estimates for anticipated quality department services.
Function as a resource for applicable ISO Program and QSR Program requirements.
Review new program drawings/information/customer specifications to understand program requirements.
Determine quality and reliability standards and ensure dimensional and cosmetic requirements, as well as customer specifications, are defined and understood.
Draft program Quality Plan and metrology labor plan.
Draft other required quality documentation such as Dimensional Visual Quality Requirements (DVQR’s) and new product inspection techniques.
Confirm customer agreement on GD&T callouts/interpretations and all critical dimensions of program when required.
Prepare Failure Mode Effects Analysis (FMEA), as needed.
Prepare Traveler Document.
Develop required Control/Test methods.
Ensure First Article Inspection (FAI) and Capability Studies are scheduled and completed.
Complete FAI and capability study analysis for submission to customer.
Author operational qualification (OQ) and performance qualification (PQ) protocols and provide training for protocol participants.
Oversee the execution of assigned OQ and PQ studies.
Author OQ and PQ Completion Reports.
Establish “golden sample” standards and prepare and submit to customer via customer approval form (CAF) as required.
Attend program team meetings to address quality-related matters.
Perform assigned activities in a timely manner.
Provide continuous quality engineering support through program end of life.
Complete Certificates of Conformance (CoC) for outgoing products, where required.
Collect and analyze production line data to monitor yield and defect performance.
Ensure golden samples are retained and controlled.
Maintain Device History Records (DHR) as necessary.
Perform periodic risk assessments, as required.
Assist Purchasing Department with maintaining vendor quality requirements.
Continuously monitor production to identify quality-related customer issues and support corrective action plans when necessary.
Issue or authorize CCR’s as needed.
Manage the return of goods, assignments and close out of RC/CA.
Conduct root cause investigation and develop corrective action plans for assigned problem reports (PSRs) and quality issues.
Manage product and process change control and notification to ensure required Engineering Change Orders (ECOs) are generated and approved by the customer prior to implementation.
Attend program team meetings as necessary to resolve program quality issues to maintain customer satisfaction.
Support QBR’s with customer and provide/present quality-related topics.
Participate 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.