We are seeking a Quality Engineer to engage with internal departments, overseeing activities related to quality control and assurance of industrial processes, materials, and products. This role entails leading problem-solving efforts to enhance manufacturing processes. Additionally, the position involves collaborating with external customers, suppliers, and internal teams to fulfill Advanced Product Quality Planning (APQP) obligations and perform validation for all new products or modifications, including implementing corrective actions.

JOB DESCRIPTION

Key responsibilities include:

• Coordinate validations for new and revised products. Regularly compile PPAP and Validation reports and develop procedural manuals.
• Conduct quality-engineering reviews of design documentation to ensure compliance with specified requirements, encompassing customer quality manuals and company records.
• Partner with Layout Technicians and Project Engineers to define and review dimensional inspection processes, including fixture development, inspection instructions, and Test Method Validation (TMV).
• Utilize statistical process control (SPC) techniques to analyze data, evaluate current processes, and propose improvements. Conduct data analysis using tools like Minitab, Microsoft Excel, or similar software.
• Interface with customers to address quality concerns and implement corrective actions to prevent recurrence.
• Employ a structured problem-solving approach, including problem definition, data collection and analysis, identification of escalation points, and recommendation of solutions.
• Maintain and update quality instructions for manufacturing processes.
• Conduct internal audits of quality procedures to ensure adherence to standards.
• Support the company's Continuous Improvement initiatives.

Job Requirements & Working Conditions:

• Bachelor's degree in engineering, Quality, or related field required.
• At least 2 years of combined experience in quality and manufacturing, with preference for custom injection molding experience.
• Proficiency in applying statistical techniques and methods.
• Strong verbal, written, and interpersonal communication skills.
• Familiarity with relevant regulations and standards such as FDA, ISO 13485, IATF 16949, and MedAccred.
• Knowledge of process validation and verification activities, including Risk analysis, Process FMEA, Process Flow Charts, and Control Plans.
• Ability to work independently and in multifunctional teams.
• Competence in basic algebra, geometry, SPC, and analytical calculations, with strong blueprint reading skills including tolerance review and knowledge of GD&T principles.
• Advanced computer skills in Windows environment, proficiency in problem-solving and statistical software (preferably Minitab). Experience with IQMS or related ERP/MRP manufacturing software preferred. Solidworks/CAD proficiency is advantageous.
• This an in-office role. Remote work is not available for this role at this time.

This role offers a dynamic opportunity to contribute to quality assurance and process improvement within a dedicated team environment.