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Quality Control Specialist
2 months ago
Innovate Motion with Johnson Electric
The Quality Assurance Associate plays a crucial role in supporting the entire Quality Assurance (QA) framework within the Quality Management System (QMS). Reporting directly to the Quality & Regulatory Manager, this position is responsible for leading all customer and third-party quality assessments. As a representative on Design Project Teams, the QA Associate ensures that all input requirements—whether internal, external, or customer-driven—are thoroughly defined, risk assessments are conducted, and that the output aligns with these requirements, supported by objective evidence.
Key Responsibilities:
- Guarantee that customer and regulatory standards are upheld throughout the product development lifecycle.
- Design and implement a medical quality system in accordance with ISO13485 and client specifications. Develop necessary procedures for production, calibration, inspection, and maintenance.
- Utilize quality 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. Support investigations and the implementation of corrective and preventive actions.
- Contribute to the development, review, and approval of process and equipment validation/qualifications (IQ, OQ, PQ). Enhance inspection plans, standard work sheets, and product specifications.
- Engage in continuous improvement initiatives. Support Kaizen efforts and strategies for reducing rework and scrap.
Qualifications:
- Bachelor's degree required.
- Local candidates preferred.
- Must possess the right 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 experiences.
- Familiarity with quality tools such as Gage R&R/MSA, calibration, NCMR, Root Cause Analysis, FMEA, FTA, and risk analysis.
- Experience with FDA regulations and ISO 13485 standards.
- Proficient in creating validations.
What We Offer:
Johnson Electric provides exceptional opportunities for talented employees to advance their professional skills and develop rewarding careers. We offer a comprehensive benefits package that includes medical, dental, and vision coverage, prescription plans, disability insurance, life insurance, a 401K match, and generous holiday and vacation benefits.
