Applied Medical Technology, Inc. (AMT)
Quality Manager
Applied Medical Technology, Inc. (AMT), Brecksville, Ohio, United States, 44141
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Quality Manager
role at
Applied Medical Technology, Inc. (AMT) .
Overview Since 1985, AMT has specialized in enteral device product development, design, manufacturing, and engineering at its state‑of‑the‑art facility near Cleveland, Ohio. The company’s steady growth creates opportunities across Northeast Ohio while retaining a small‑company culture that serves users worldwide.
Position Summary This role coordinates and manages Quality Assurance activities throughout all production and manufacturing processes. The manager ensures that quality standards are met, communicates vital information across the organization, and leads continuous improvement efforts.
Duties and Responsibilities
Assist in troubleshooting raw material issues and report findings to appropriate personnel.
Interpret and enforce company policies during government and third‑party audits.
Develop and modify regulatory procedures to remain compliant with FDA, ISO, European, Canadian, and other standards.
Process, execute, organize, and archive internal documentation related to Engineering and Quality Systems.
Prepare and submit regulatory filings, including FDA 510(k) pre‑market notifications and product listings.
Investigate and review complaints, determine reportability, notify authorities, and track trends.
Conduct trend analysis and prepare complaint reports biannually.
Review Engineering Change Orders (ECOs) for regulatory impact.
Ensure QMS changes uphold device safety and regulatory compliance.
Approve Engineering Test Protocols and Reports.
Manage complaints, testing, calibration, and training programs.
Provide QMS training to employees.
Facilitate external audits.
Gather employee input for performance improvement.
Minimum Qualifications
Four‑year Engineering degree.
1‑5 years of experience in a regulated environment, preferably in medical devices.
Proficiency with MS Office.
Familiarity with mechanical and electrical test equipment.
Knowledge of medical device manufacturing concepts and procedures.
Ability to analyze and aggregate data using statistics.
Experience with ISO 13485, ISO 14971, and FDA QSR for Medical Devices preferred.
Benefits
Medical, dental, and vision insurance beginning the first of the month after 30 days of service.
Hospital indemnity, critical illness, term life insurance, and long‑term disability (company paid).
401(k) with 100% match up to 3% of salary.
Paid time off, inclusive of nine paid holidays and additional PTO based on length of service.
Tuition reimbursement, employee referral bonus, and employee assistance program.
On‑site vending, gym, and annual employee appreciation picnic.
AMT is an Equal Opportunity/Affirmative Action Employer.
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Quality Manager
role at
Applied Medical Technology, Inc. (AMT) .
Overview Since 1985, AMT has specialized in enteral device product development, design, manufacturing, and engineering at its state‑of‑the‑art facility near Cleveland, Ohio. The company’s steady growth creates opportunities across Northeast Ohio while retaining a small‑company culture that serves users worldwide.
Position Summary This role coordinates and manages Quality Assurance activities throughout all production and manufacturing processes. The manager ensures that quality standards are met, communicates vital information across the organization, and leads continuous improvement efforts.
Duties and Responsibilities
Assist in troubleshooting raw material issues and report findings to appropriate personnel.
Interpret and enforce company policies during government and third‑party audits.
Develop and modify regulatory procedures to remain compliant with FDA, ISO, European, Canadian, and other standards.
Process, execute, organize, and archive internal documentation related to Engineering and Quality Systems.
Prepare and submit regulatory filings, including FDA 510(k) pre‑market notifications and product listings.
Investigate and review complaints, determine reportability, notify authorities, and track trends.
Conduct trend analysis and prepare complaint reports biannually.
Review Engineering Change Orders (ECOs) for regulatory impact.
Ensure QMS changes uphold device safety and regulatory compliance.
Approve Engineering Test Protocols and Reports.
Manage complaints, testing, calibration, and training programs.
Provide QMS training to employees.
Facilitate external audits.
Gather employee input for performance improvement.
Minimum Qualifications
Four‑year Engineering degree.
1‑5 years of experience in a regulated environment, preferably in medical devices.
Proficiency with MS Office.
Familiarity with mechanical and electrical test equipment.
Knowledge of medical device manufacturing concepts and procedures.
Ability to analyze and aggregate data using statistics.
Experience with ISO 13485, ISO 14971, and FDA QSR for Medical Devices preferred.
Benefits
Medical, dental, and vision insurance beginning the first of the month after 30 days of service.
Hospital indemnity, critical illness, term life insurance, and long‑term disability (company paid).
401(k) with 100% match up to 3% of salary.
Paid time off, inclusive of nine paid holidays and additional PTO based on length of service.
Tuition reimbursement, employee referral bonus, and employee assistance program.
On‑site vending, gym, and annual employee appreciation picnic.
AMT is an Equal Opportunity/Affirmative Action Employer.
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