AirClean Systems
Quality Assurance Supervisor
Join AirClean Systems as a Quality Assurance Supervisor in Cleveland, OH. This role coordinates and manages QA activities across all production processes, ensuring compliance with FDA, ISO, European, and Canadian standards. Position Summary
The supervisor will communicate vital information to personnel, troubleshoot raw material issues, and manage complaint and calibration processes. This role involves external audit facilitation, training, and regulatory filing preparation. Duties and Responsibilities
Assist in troubleshooting raw material issues and create reports for personnel. Interpret and communicate company policies to auditors and enforce safety regulations. Create and modify regulatory procedures and maintain compliance with FDA 510(k), ISO, and other standards. Process, execute, and archive internal documentation related to Engineering and Quality Systems. Prepare regulatory filings and investigate and review complaints. Analyze incoming complaints, notify authorities, and track trends. Review engineering change orders, QMS changes, and engineering test protocols. Manage complaints, testing, calibration, and training; facilitate external audits. Train employees on QMS changes and provide feedback on strengths and improvement areas. Qualifications
Four‑year engineering degree. 1–5 years experience in a regulated environment, preferably medical devices. Proficiency with MS Office and mechanical/electrical test equipment. Knowledge of medical device manufacturing concepts and statistical data analysis. Experience with ISO 13485, ISO 14971, and FDA QSR preferred. Knowledge, Skills, and Abilities
Strong communication and presentation skills. Ability to analyze data and produce reports. Basic mathematical and reasoning skills for problem solving. Additional Requirements
Valid driver’s license. Background check (drug, alcohol, credit, criminal) may be required. Benefits
Medical, dental, and vision insurance after 30 days. Company‑paid hospital indemnity and critical illness insurance. 401(k) match up to 3% of salary. Paid time off and nine paid holidays; PTO accrues from day one. Perks
Positive working environment and on‑site vending and gym. Annual employee appreciation picnic and tuition reimbursement. Employee referral and assistance programs. AMT is an Equal Opportunity/Affirmative Action Employer.
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Join AirClean Systems as a Quality Assurance Supervisor in Cleveland, OH. This role coordinates and manages QA activities across all production processes, ensuring compliance with FDA, ISO, European, and Canadian standards. Position Summary
The supervisor will communicate vital information to personnel, troubleshoot raw material issues, and manage complaint and calibration processes. This role involves external audit facilitation, training, and regulatory filing preparation. Duties and Responsibilities
Assist in troubleshooting raw material issues and create reports for personnel. Interpret and communicate company policies to auditors and enforce safety regulations. Create and modify regulatory procedures and maintain compliance with FDA 510(k), ISO, and other standards. Process, execute, and archive internal documentation related to Engineering and Quality Systems. Prepare regulatory filings and investigate and review complaints. Analyze incoming complaints, notify authorities, and track trends. Review engineering change orders, QMS changes, and engineering test protocols. Manage complaints, testing, calibration, and training; facilitate external audits. Train employees on QMS changes and provide feedback on strengths and improvement areas. Qualifications
Four‑year engineering degree. 1–5 years experience in a regulated environment, preferably medical devices. Proficiency with MS Office and mechanical/electrical test equipment. Knowledge of medical device manufacturing concepts and statistical data analysis. Experience with ISO 13485, ISO 14971, and FDA QSR preferred. Knowledge, Skills, and Abilities
Strong communication and presentation skills. Ability to analyze data and produce reports. Basic mathematical and reasoning skills for problem solving. Additional Requirements
Valid driver’s license. Background check (drug, alcohol, credit, criminal) may be required. Benefits
Medical, dental, and vision insurance after 30 days. Company‑paid hospital indemnity and critical illness insurance. 401(k) match up to 3% of salary. Paid time off and nine paid holidays; PTO accrues from day one. Perks
Positive working environment and on‑site vending and gym. Annual employee appreciation picnic and tuition reimbursement. Employee referral and assistance programs. AMT is an Equal Opportunity/Affirmative Action Employer.
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