Quality Engineer; Manufacturing

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 across seven plants located throughout the eastern United States.

Mack Molding offers a variety of services across its facilities, providing diverse career paths and advancement opportunities. When new opportunities arise—whether on the manufacturing floor, in the field, or in the corporate offices—Mack strives to promote from within.

• Provide support to new business development relating to quality matters as needed
• Draft preliminary Quality Plans, if appropriate
• Provide cost and time estimates for anticipated quality department services such as metrology or validation services
• Serve as a resource for applicable ISO and QSR Program requirements

• Review new program drawings, information, and customer specifications to understand requirements
• Determine quality and reliability standards ensuring dimensional, cosmetic, and customer specifications are met
• Draft program Quality Plans and metrology labor plans, including fixture, calibration, and measurement requirements
• Create other quality documentation such as DVQRs and inspection techniques
• Confirm customer agreement on GD&T callouts and critical dimensions
• Prepare FMEA, Traveler Document, and develop control/test methods
• Ensure FAI and capability studies are scheduled and completed, and analyze results for customer submission
• Author protocols for OQ and PQ, provide training, oversee execution, and prepare completion reports
• Establish golden sample standards and submit for customer approval
• Attend program meetings to address quality issues
• Perform activities in a timely manner

• Complete Certificates of Conformance for outgoing products
• Monitor production data to assess yield and defects
• Retain and control golden samples, maintain DHRs
• Conduct risk assessments and support vendor quality requirements
• Monitor production for quality issues, support corrective actions, and manage product/process change controls
• Participate in program meetings and audits, support customer quality topics

Qualifications include working knowledge of statistical techniques, sampling plans, and Quality Systems Regulations. A Bachelor’s degree in a technical field is preferred, along with two years of related experience. Experience in medical device manufacturing and familiarity with Six Sigma or Lean methodologies are also preferred.