Senior Quality Assurance Specialist
7 days ago
AJR Enterprises, LLC. is a leading contract manufacturer of superior medical devices and advanced manufacturing solutions within the medical device industry. Our 180,000 square foot facility in St. Charles, Illinois serves as our headquarters and manufacturing site.
We are committed to delivering the highest quality products and providing exceptional customer satisfaction in the medical device industry.
Job Summary:
We are seeking an experienced Senior Quality Assurance Specialist to join our team. In this role, you will be responsible for ensuring compliance with quality related engineering needs of the organization.
Responsibilities:
- Lead in supporting compliance for medical device manufacturers in ID/Traceability throughout supply chain
- Manage Acceptance Activities, Non-conforming material management, Packaging/Labeling control, Production/Process controls, Process Validation
- Conduct Risk Assessments, project meetings, pilot builds, First Article Inspections, and Post Market Risk Management
- Design and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment
- Design and execution of pFEMA's, IQ, OQ, PQ and PPQ validation
- Corrective and Preventive Action management, facilitation, ownership and problem resolution
- Process improvement and support, including Quality System process review and revision
- Training assistance, including providing training in quality system activities/requirements
- Internal and external audit coordination and facilitation
Requirements:
- A Bachelor's degree in science, engineering or equivalent
- 10 or more year's relevant experience
- At least 5 years' experience in medical device manufacturing
- Strong knowledge of Quality Systems policies and regulations (ISO 13485 and FDA Part 820) with a strong background in medical device quality assurance and processes
- Experience conducting supplier audits and writing supplier contracts
- Familiarity with statistical analysis
Compensation:
$110,000 - $140,000 per annum, depending on experience
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