Quality Assurance Manager
12 hours ago
Staff Icons is seeking a highly skilled Quality Assurance Manager to oversee the quality control program and ensure compliance with regulatory standards.
Key Responsibilities:- Develop and implement quality control programs to ensure compliance with regulatory standards.
- Conduct internal quality audits and provide recommendations for improvement.
- Assist with and review method/instrument validations.
- Oversee proficiency survey programs and maintain compliance with regulatory standards.
- Review and maintain standard operating procedures.
- Ensure proper qualification of laboratory personnel and maintain compliance with CLIA, CAP, and NYS standards.
- Serve as a quality resource for problem-solving and process improvement.
- Investigate and document non-conforming events, non-conforming products, and CAPAs as necessary.
- Monitor and ensure implementation of goals to meet established quality assurance, quality control, quality improvement plans, and turnaround time.
- Ensure compliance with regulatory agency standards through maintaining proper documentation, conducting audits, and ensuring proper corrective actions.
- Address internal and external complaints, proficiency failures, and biases.
- Bachelor of Science degree in medical technology or related science.
- 4 years clinical laboratory or clinical quality compliance experience.
- 2 or more years of quality experience.
- 2 or more years of supervisory experience (preferred).
- ASCP or other national certification preferred.
- ASQ a plus.
- Working knowledge of tools, methods, and concepts of quality assurance.
- Prior auditing experience preferred.
- Solid knowledge of relevant regulatory standards (FD plus).
- Strong analytical skills and problem-solving abilities.
- Excellent communication and writing skills.
- Strong computer (Word, Excel, Outlook) skills.
- Travel required-25% - Local travel.
Staff Icons is an equal opportunity employer and welcomes applications from diverse candidates.
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