Permanent position for a Quality Assurance Associate supporting device manufacture, test, release, and field support under an FDA- and ISO-regulated quality system.
Maintain quality management system processes spanning controlled documents, record retention, and Good Documentation Practices.
Review production, device history, lot, and inspection records to support product disposition.
Review and release first article inspection and inspection plan documentation.
Serve as day-to-day quality contact for production on process adherence, drawings, specifications, and cGMP expectations.
Drive nonconformance and CAPA records from initiation through investigation, root cause, effectiveness verification, and closure.
Support supplier qualification and performance monitoring, including review of incoming certificates and test data.
Administer the calibration program, covering schedule maintenance, certificate review, and out-of-tolerance impact assessment.
Assess change requests for documentation and training impact, and compile quality metrics and trends for management review.
Requirements
Associate or bachelor’s degree in a scientific or technical discipline.
0-2 years in quality assurance or quality systems within a regulated manufacturing environment (medical device, pharmaceutical, or biotech).
Working knowledge of ISO 13485 and FDA 21 CFR Part 820.
Hands-on experience with nonconformance, CAPA, and change control records.
Familiarity with Good Documentation Practices and controlled record retention.
Clear technical writing and accurate recordkeeping under audit scrutiny.
Ability to manage concurrent priorities across production and quality functions.
Effective cross-functional communication with manufacturing, engineering, and suppliers.
Experience with calibration or supplier quality programs a plus.
