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Quality Assurance Associate
2 months ago
Come Innovate Motion with usThe QualityAssurance Associate will support all aspects of the Quality Assurance (QA) program within the Quality Management System (QMS). The QE reports to the Q&R Manager. This position will lead all customer and third-party quality audits. Participate in Design Project Teams as a QE/QA Representative to ensure that input requirements (internal, external, and customer) are clearly defined, risk assessment is performed, output meets input requirements, and objective evidence clearly supports conclusions. Perform quality related design control activities as assigned by Design Project Team. Partner with production during Design Transfer phase to ensure that products and processes meet all quality requirements. Your responsibilities will be:
Ensure customer and regulatory requirements are met along the product development cycle.
Develop and implement medical quality system per ISO13485 and customer requirements. Create production, calibration, inspection, and maintenance procedures as required.
Use Failure Modes Effects Analysis (FMEA), Fault Tree Analysis (FTA), Fish Bone Diagram, Risk Analysis, or other appropriate quality tools to define and manage risk or identify root cause of failure.
Assist and/or complete with the resolution of quality issues related to non-conformance reports, customer complaints, regulatory actions, etc. Support CAPA investigations and related corrective and preventive actions.
Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ). Develop, review and improve inspection plans, standard work sheet and product drawings.
Work on continuous improvement activities. Support Kaizen activities and re-work/scrap reduction.
Our Requirements
Bachelor's degree
Local Candidate Required
The right to work in the United States without Sponsorship
1+ Years' experience in a medical device Manufacuring setting not including Internship and Co-Op experience
Familiarity with quality tools i.e. Gage R&R/MSA, calibration, NCMR, Root Cause Analysis and related problem-solving techniques, FMEA, FTA, Fish Bone Diagram, risk analysis
Experience with FDA regulations and ISO 13485
Experience with creating validations
What We offer: JE offers talented employee's exceptional opportunities to learn and grow professionally with rewarding careers. We offer a competitive benefits package including medical, dental, prescription plan, vision, disability coverage, life insurance coverage, 401K match, and holiday/vacation benefits.Come join our global, inclusive & diverse teamOur purpose is to improve the quality of life of everyone we touch through our innovative motion systems. We are a truly global team bound together by our shared values. Our culture is built on the diversity, knowledge, skills, creativity, and talents that each employee brings to the company. Our people are our company's most valuable asset. We are committed to providing an inclusive, diverse and equitable workplace where employees of different backgrounds feel valued and respected, regardless of their age, gender, race, ethnicity or religious background. We are committed to inspiring our employees to grow, act with ownership and find fulfilment and meaning in the work they do.
