Senior Quality Assurance Specialist
4 days ago
The Sr. Quality Assurance Specialist will be responsible for managing and implementing quality assurance processes to ensure the company's products meet the highest quality standards. This includes reviewing and approving device history records, managing internal audits, and supporting external audits.
Key Responsibilities:- Manage quality assurance processes to ensure compliance with regulatory requirements
- Review and approve device history records and inspection records
- Manage internal audits, including creating and managing the annual internal audit schedule
- Support external audits through preparation activities and coordination
- Represent the organization on behalf of QA with external partners
- Review and approve change control documents
- Establish and manage key performance indicators
- Manage and lead root cause and corrective actions investigations
- Review and approve IQ/OQ/PQ for equipment, instruments, or facilities
- Develop training materials related to quality system processes
Medical Components, Inc. develops, manufactures, markets, and supports cutting-edge vascular access devices and accessories. Our company's engineering and applications expertise provides superior products that meet the clinical needs of the medical industry.
Our Offerings:- Competitive compensation
- Health, Dental, Vision coverage
- FSA
- Life Insurance
- 401k
- Paid Holidays
- Generous PTO
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Harleysville, Pennsylvania, United States Trotter Workforce Full time{"h3": "Job Summary", "p": "Trotter Workforce is seeking a Quality Assurance Process Control Technician to provide support to the QA Department, production, shipping and receiving. The ideal candidate will implement and monitor procedures and processes to ensure product quality is produced, packaged and shipped to specifications.", "ul": [{"li": "Coordinate...
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