Quality Control Specialist

2 weeks ago


Columbus, Ohio, United States Johnson Electric Full time

Join Johnson Electric in Driving Quality Excellence

The Quality Assurance Associate plays a pivotal role in the execution of the Quality Assurance (QA) program within the Quality Management System (QMS). Reporting directly to the Quality & Regulatory Manager, this position is responsible for leading customer and third-party quality audits. The role involves active participation in Design Project Teams as a QA/QE Representative to ensure that all input requirements—whether internal, external, or customer-driven—are clearly articulated, risk assessments are conducted, and that outputs align with established input requirements. Furthermore, objective evidence must be meticulously documented to substantiate conclusions.

Key Responsibilities Include:

  • Ensuring compliance with customer and regulatory standards throughout the product development lifecycle.
  • Developing and implementing a medical quality system in accordance with ISO13485 and customer specifications. This includes creating necessary production, calibration, inspection, and maintenance procedures.
  • Utilizing quality tools such as Failure Modes Effects Analysis (FMEA), Fault Tree Analysis (FTA), and Risk Analysis to effectively manage risks and identify root causes of failures.
  • Assisting in the resolution of quality-related issues, including non-conformance reports and customer complaints, while supporting CAPA investigations and corrective actions.
  • Contributing to the development, review, and approval of process and equipment validation/qualifications (IQ, OQ, PQ) and enhancing inspection plans and product documentation.
  • Engaging in continuous improvement initiatives, including Kaizen activities and efforts to reduce rework and scrap.

Qualifications:

  • Bachelor's degree in a relevant field.
  • Local candidates are preferred.
  • Authorization to work in the United States without sponsorship.
  • A minimum of 1 year of experience in a medical device manufacturing environment, excluding internships and co-op positions.
  • Proficiency with quality tools such as Gage R&R/MSA, calibration, NCMR, and Root Cause Analysis.
  • Familiarity with FDA regulations and ISO 13485 standards.
  • Experience in creating validation documents.

What We Offer:

Johnson Electric provides exceptional opportunities for talented employees to develop and advance their careers. We offer a comprehensive benefits package that includes medical, dental, vision, disability coverage, life insurance, 401K matching, and generous holiday and vacation benefits.



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