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Mack Molding Company · 1 day ago

Quality Engineer - Medical Devices

Arlington, VT

Full-time

Onsite

Mid Level

Mack Molding Company is seeking a Quality Engineer to provide quality engineering support during new business development and program launches for medical devices. The role involves ensuring that manufacturing processes and finished products meet all applicable regulatory and quality requirements, while also supporting customer audits and managing quality documentation.

AutomotiveIndustrialManufacturing

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 CFR Part 820 and ISO 13485 regulatory 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

Support customer audits, regulatory inspections, and certification

Drafts program Quality Plan, PFMEA, and Dynamic Control Plans as required

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 manufacturing job travelers and associated process documents

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

Generates validation plans, operational qualification (OQ), performance qualification (PQ) protocols, and provides training for protocol participants

Oversees the execution of assigned validation activities to ensure compliance with protocol requirements and completion of study tasks

Generates Required validation completion reports to include resolution of any deviations recorded and overall study conclusion

Perform first-piece and in-process approvals for new setups, tooling changes, or process adjustments

Attends program team meetings to support production-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

Use statistical tools (SPC, DOE, capability studies) to identify process improvement opportunities

Maintains Device Master Records including Device History Records as required

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 customer complaints and returns as needed

Manages the return of goods, assignments and close out of RC/CA

Documents nonconformances, conducts thorough root cause analyses, and develops and implements effective corrective action plans

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 quality business reviews 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

Qualification

Quality Systems RegulationsISO 13485Statistical techniquesRoot cause analysisAdvanced Product Quality PlanningMinitabManufacturing processesAnalytical skillsProblem-solving skills

Required

Provides quality engineering support during new business development, program launches, and for existing customers

Ensure that manufacturing processes, quality systems, and finished products for medical devices meet all applicable regulatory, customer, and internal quality requirements

Working in an ITAR-controlled environment

Strong technical background

Problem-solving skills

Ability to work within the strict compliance requirements of ITAR regulations

Support new business development relating to quality matters as needed