Experience Requirements
This position will provide technical support in quality engineering functions in product development in compliance with FDA 21CFR Part 820, ISO 13485 and internal procedures
Qualification Requirements
4 year college degree (technical degree preferred) Quality Assurance experience in a R&D environment or manufacturing experience. Min 3-5 years Eventual ASQ certification highly desired.
Preferred Qualifications
Computer literate (MS Word, Excel, Access, PowerPoint, and Mini-tab preferred. Good oral and written communication skills Ability to prioritize and work independently Statistical Skills (DOE, SPC, Reliability, Gage R&R) Regulatory cGMP, QSR and ISO knowledge base Experience with risk analysis methodologies Validation concepts and techniques (process, equipment, and gauging) Able to work independently with limited supervision.
Responsibilities
The position will be responsible for direct quality activities in R&D: Study protocal review and approval. Support product development such as design change and review, quality planning, risk evaluation, and validation. Supervise quality documentation as needed. Coordinate Corrective and Preventive Action (CAPA) for customer, internal, and vendor related needs. Participate in Continuous Improvement Projects (CIP) for both processes and business systems. Develop training programs for engineering. Serve as Management Representative for the site. Represent company during customer or regulatory audits as needed.
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