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Quality Control Specialist
2 months ago
Innovate Motion with Johnson Electric
The Quality Assurance Associate plays a pivotal role in supporting the comprehensive 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 associate will also participate in Design Project Teams as a QA representative, ensuring that all input requirements (internal, external, and customer) are well-defined, risk assessments are conducted, and that outputs align with input requirements, with objective evidence supporting all conclusions.
Key Responsibilities:
- Ensure that customer and regulatory standards are met throughout the product development lifecycle.
- Develop and implement a medical quality system in accordance with ISO13485 and customer specifications. This includes creating necessary production, calibration, inspection, and maintenance procedures.
- Utilize quality tools such as Failure Modes Effects Analysis (FMEA), Fault Tree Analysis (FTA), Fish Bone Diagram, and Risk Analysis to effectively manage risks and identify root causes of failures.
- Assist in resolving quality issues related to non-conformance reports, customer complaints, and regulatory actions. Support Corrective and Preventive Action (CAPA) investigations and related initiatives.
- Contribute to the development, review, and approval of process and equipment validation/qualifications (IQ, OQ, PQ). Enhance inspection plans, standard work sheets, and product drawings.
- Engage in continuous improvement initiatives, supporting Kaizen activities and efforts to reduce re-work and scrap.
Qualifications:
- Bachelor's degree in a relevant field.
- Local candidates are 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.
- Proficiency in creating validations.
What We Offer:
Johnson Electric provides exceptional opportunities for talented employees to learn and grow professionally within rewarding careers. We offer a competitive benefits package that includes medical, dental, prescription plans, vision, disability coverage, life insurance, 401K matching, and holiday/vacation benefits.
