Quality Assurance Specialist
5 days ago
Job Summary:
The Quality Control Administrator plays a vital role in ensuring the quality and compliance of our medical devices. This position is responsible for performing and ensuring that product documentation is complete, accurate, and compliant with ISO 13485 standards and FDA regulations.
Key Responsibilities:
- Quality System Compliance: Understand, support, and comply with the Company Quality System requirements.
- Work Environment: Maintain a safe and clean work environment.
- Standard Operating Procedures: Follow the standard operating procedures and written work instructions.
- Communication: Openly communicate with the Company team members.
- Device History Record Review: Perform Device History Record (DHR) review for production and RGA products.
- Label Inspection: Perform label inspection on product labeling.
- Certificate of Conformance: Generate product Certificate of Conformance (C of C) documents for production and RGA.
- Product Acceptance: Perform final acceptance of product before customer shipment.
- Sterilization Process Review: Review sterilization process data and reports for compliance.
- Continuous Improvement: Identify and support continuous improvement efforts with Supervisor.
- Special Projects: Take on special projects as assigned.
Other Responsibilities:
- Quality Verification: Verifies work affecting quality independently and has the authority to perform these tasks as stated in the responsibilities section.
- Job Description Disclaimer: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Qualifications:
- Regulated Manufacturing Experience: 3-5 years in a regulated manufacturing environment, experience in an ISO 13485:2016 manufacturing environment is preferred.
- Mechanical Aptitude: Strong mechanical aptitude abilities.
- Communication Skills: Ability to communicate effectively through oral and written communications.
- Collaboration: Ability to work with others collaboratively.
- Attention to Detail: Attention to detail to understand and meet the requirements.
- Organizational Skills: Strong organizational skills.
- Verbal Communication: Strong verbal communication skills.
- Problem Solving: Demonstrated problem-solving ability in a cross-functional environment.
- Task and Time Management: Take responsibility for task and time management.
Physical Requirements:
This position requires working in an office setting. This includes sitting at a desk working on a computer for long periods of time. It also could include lifting 40 pounds and standing for long periods of time as well as walking the facility.
Attendance: This position requires 100% on-site attendance.
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