Quality Assurance Specialist
1 week ago
**Medica USA: Leading the Way in Medical Device Quality**
At Medica USA, we are committed to delivering high-quality medical devices that meet the highest standards of safety and efficacy. We are seeking a highly skilled Senior Lab Technician to join our team, responsible for ensuring compliance with regulatory requirements and maintaining the highest level of quality in our laboratory operations.
Job Summary:The Senior Lab Technician will be responsible for performing testing and review of results, demonstrating laboratory troubleshooting skills, and conducting equipment maintenance. This role will also involve preparing test orders and specimens for testing, performing inspections/testing and quality release in a clean room environment, and supporting audits as required.
We are looking for a self-directed individual with excellent attention to detail, strong communication skills, and a working knowledge of computer software. If you have 3-5 years of experience in medical devices and manufacturing, exposure to ISO and FDA regulations, and a Bachelor's degree or Associates Degree, we encourage you to apply.
Key Responsibilities:- Testing and Review: Perform testing and review results to ensure compliance with regulatory requirements.
- Laboratory Troubleshooting: Demonstrate laboratory troubleshooting skills and critical thinking to resolve issues efficiently.
- Equipment Maintenance: Conduct equipment maintenance and daily QC to ensure optimal performance.
- Test Order Preparation: Prepare test orders and specimens for testing and/or transfer to reference laboratory.
- Clean Room Environment: Perform inspections/testing and quality release in a clean room environment.
- Audit Support: Support audits as required to ensure compliance with regulatory requirements.
- Education: Bachelor's degree or Associates Degree.
- Experience: 3-5 years of experience in medical devices and manufacturing.
- Regulatory Knowledge: Exposure to ISO and FDA regulations.
- Communication Skills: Strong verbal and written communication skills.
- Computer Skills: Working knowledge of computer software, including MS Outlook, MS Word, and Excel.
- Attention to Detail: Excellent attention to detail and organizational skills.
$85,000 - $95,000 per annum, depending on experience.
Please note that salary estimates may vary based on location and other factors.
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