Quality Assurance Specialist

2 days ago


Sheboygan, Wisconsin, United States Timothy Jon & Associates Full time

We are seeking a Quality Assurance Specialist to oversee quality control and assurance of industrial processes, materials, and products. This role entails leading problem-solving efforts to enhance manufacturing processes and collaborating with external customers, suppliers, and internal teams to fulfill Advanced Product Quality Planning (APQP) obligations.


Key Responsibilities:
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.
Partner with Layout Technicians and Project Engineers to define and review dimensional inspection processes.
Utilize statistical process control (SPC) techniques to analyze data and propose improvements.
Interface with customers to address quality concerns and implement corrective actions.
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.

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.



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