Medical Device Quality Assurance Specialist
1 week ago
The Quality Assurance Technician is responsible for ensuring the quality of medical devices throughout the production process. This includes verifying the conformance of purchased products and materials, as well as performing inspections and testing to ensure compliance with regulatory requirements.
Key Responsibilities:- Quality Control: Perform receiving inspections, in-process quality inspections, and finished goods acceptance to ensure quality standards are met.
- Record Keeping: Maintain accurate and detailed records of quality control activities, inspections, and testing.
- Collaboration: Work closely with quality engineers and other stakeholders to identify and address quality issues.
- Compliance: Ensure adherence to regulatory requirements, including 21 CFR 820 and ISO 13485.
- Training and Development: Participate in training and professional development to stay up-to-date on industry best practices and regulatory requirements.
- Education: High school diploma or equivalent.
- Experience: Experience in medical device quality assurance or a related field is preferred.
- Skills: Strong understanding of quality systems, regulatory requirements, and inspection techniques. Proficient in Microsoft Office applications and able to use hand tools, calibrated instruments, and measurement equipment.
- Communication: Excellent written and verbal communication skills, with the ability to work effectively in a team environment.
BHI Energy is an equal opportunity employer and welcomes applications from diverse candidates.
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