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Mack Molding Company · 1 month ago

Quality Engineer - Medical Devices

Arlington, Vermont, United States

Full-time

Onsite

Mid Level

3+ years exp

Mack Molding Company is a leading manufacturer in the medical device sector, seeking a Quality Engineer to provide quality engineering support during new business development and program launches. The role involves ensuring manufacturing processes and quality systems meet regulatory and internal standards while supporting existing customer requirements.

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 (DVQR’s) 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

ISO 1348521CFR Part 820Statistical techniquesSix SigmaLean manufacturingQuality Engineering certificationAnalytical skillsTechnical proficiencyProblem-solvingCommunication skills

Required

Minimum education requirements are a H.S. diploma with three or more years of related quality experience

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations

Ability to write reports, business correspondence, and procedure manuals

Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public

Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry

Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals

Ability to apply concepts such as fractions, percentages, ratios, and to draw and interpret bar graphs

Ability to interpret a variety of technical instructions furnished in written, oral, mathematical, diagram, or schedule form and deal with abstract and concrete variables

Ability to define problems, collect data, establish facts, and draw valid conclusions

To perform this job successfully, an individual should have knowledge of, and strong working familiarity with, Microsoft Word, Access and Excel in a Windows environment

Preferred

Bachelor's degree (B.S.) in a technical (STEM or Engineering) field preferred, plus one or more years 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

Preference may be given to an individual with an ASQ Quality Engineering certification

Company

Mack Molding Company

Mack Molding Co., headquartered in Arlington, VT, provides design through FDA-approved manufacturing services to the medical, commercial, computer & business equipment, energy and transportation markets.

Founded in 1920

Milford, Connecticut, USA

1001-5000 employees