Quality Control Specialist
2 weeks ago
Join Johnson Electric in Driving Quality Excellence
The Quality Assurance Associate plays a pivotal role in upholding the standards of the Quality Assurance (QA) program within our 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 also involves active participation in Design Project Teams as a QA representative, ensuring that all input requirements—whether internal, external, or customer-driven—are well-defined, risk assessments are conducted, and that outputs align with these requirements while being supported by objective evidence.
Key Responsibilities:
- Ensure compliance with customer and regulatory standards throughout the product development lifecycle.
- Develop and implement a medical quality system in accordance with ISO13485 and customer specifications, including the creation of production, calibration, inspection, and maintenance procedures as necessary.
- Utilize quality management tools such as Failure Modes Effects Analysis (FMEA), Fault Tree Analysis (FTA), and Risk Analysis to identify and manage risks or determine root causes of failures.
- Assist in resolving quality issues related to non-conformance reports, customer feedback, and regulatory actions, while supporting CAPA investigations and related corrective and preventive measures.
- Contribute to the development, review, and approval of process and equipment validation/qualifications (IQ, OQ, PQ), and enhance inspection plans, standard work sheets, and product drawings.
- Engage in continuous improvement initiatives, supporting 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, Root Cause Analysis, FMEA, FTA, and risk analysis.
- Familiarity with FDA regulations and ISO 13485 standards.
- Experience in creating validation documentation.
What We Offer:
At Johnson Electric, we provide our talented employees with exceptional opportunities for professional growth and development. Our competitive benefits package includes medical, dental, prescription plans, vision coverage, disability insurance, life insurance, a 401K match, and generous holiday and vacation benefits.
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