Quality Engineer (Manufacturing)

Mack Molding • Arlington, VT

115d

About The Position

Mack Molding is recognized as one of the world's premier custom manufacturers of high quality complex parts, assemblies, and total products in plastic and metal. We have been in business since 1920, and have grown to over 2000 employees in seven plants located throughout the eastern United States. Mack Molding offers a variety of services throughout its numerous facilities, resulting in many diverse career paths and advancement opportunities. And when new opportunities arise, whether on the manufacturing floor, out in the field, or in the corporate offices, Mack strives to promote its talent from within.

Requirements

• Working knowledge of Statistical techniques & sampling plans
• Knowledge of Quality Systems Regulations
• Bachelors degree (B.A.) in technical field desired
• 2 years related experience preferred
• Experience in medical device-manufacturing environment preferred
• Experience with Six Sigma or Lean preferred

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

What This Job Offers

• Career Level: Entry Level
• Industry: Plastics and Rubber Products Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees