Applied Medical Technology, Inc. (AMT)
Quality Assurance Supervisor
Applied Medical Technology, Inc. (AMT), Brecksville, Ohio, United States, 44141
Quality Assurance Supervisor
Location: North Royalton, OH – Salary: $100,000-$115,000 (1 week ago)
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Applied Medical Technology, Inc. (AMT)
– a leading enteral device manufacturer located near Cleveland, Ohio.
Description Since 1985, AMT has been developing, designing, manufacturing, and engineering enteral device products in a state‑of‑the‑art facility. AMT’s steady growth provides job opportunities throughout Northeast Ohio while maintaining a small company culture with a global reach.
Position Summary Coordinate and manage Quality Assurance activities across all manufacturing processes. Ensure quality standards are met, communicate vital information to personnel, and support regulatory compliance.
Responsibilities
Assist in troubleshooting raw material issues and create/distribute reports.
Interpret and communicate company policies to auditors and enforce safety regulations.
Create 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) premarket notifications and product listings.
Investigate and review complaints; analyze incoming complaints for reportability; track and trend complaints; notify authorities as required; present complaint reports twice annually.
Review change orders (ECOs) to ensure compliance and notify regulatory bodies of changes.
Review QMS changes to ensure safety and effectiveness of the medical device and compliance with regulatory requirements.
Review and approve Engineering Test Protocols and Reports.
Manage complaints, testing, calibration, and training; train employees on QMS changes.
Facilitate external audits.
Review employee input on strengths and areas for improvement.
Qualifications
Four‑year engineering degree.
1–5 years related experience in a regulated environment, preferably medical device.
Proficiency with MS Office.
Familiarity with mechanical and electrical test equipment.
Knowledge of manufacturing concepts, practices, and procedures related to medical device manufacturing.
Ability to analyze and aggregate data using statistics.
Experience preferred with ISO 13485, ISO 14971, and FDA QSR for Medical Devices.
Language Skills Read, analyze, and interpret general business periodicals, professional journals, technical procedures, or government regulations; write reports, business correspondence, and procedure manuals; effectively present information and respond to questions from managers, clients, vendors, non‑engineers, and the general public.
Mathematical Skills Calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume; apply concepts of basic algebra and geometry; work with probability and statistical inference; apply fractions, percentages, ratios, and proportions to practical situations.
Reasoning Ability Solve practical problems and deal with a variety of concrete variables; interpret instructions; define problems, collect data, establish facts, and draw valid conclusions; interpret a wide variety of technical instructions in mathematical or diagram form and manage abstract and concrete variables.
Certificates, Licenses, Registrations Valid driver’s license.
Essential Job Functions
Mental: Communicate effectively, analyze complex data, interpret written materials, develop team, ensure compliance, respond to feedback, maintain positive relationships, troubleshoot and solve problems.
Physical: Hear, speak, use computer equipment; potentially operate a lathe, mill, or electrical/general hand tools; moderate noise; limited exposure to physical risk.
Knowledge, Skills, and Abilities Modern business communication, office procedures and methods; personal computer and Microsoft Office; establish priorities, work independently, and facilitate teamwork.
Equipment Used Telephones, computer, office equipment, electrical and general hand tools.
Special/Additional Requirements Background check: drug, alcohol, credit, and/or criminal.
Equal Opportunity/Affirmative Action AMT is an Equal Opportunity/Affirmative Action Employer.
Benefits
Insurance: Medical, dental, vision at first of month following 30 days of service.
Other Benefits: Hospital indemnity, critical illness, term life, long‑term disability (company paid), and others.
401(k): 100% match up to 3% of salary.
Paid Time Off (PTO): Nine paid holidays plus PTO based on length of service, starting day one.
Other Exciting Perks
Family‑oriented, positive working environment.
Discretionary yearly raises.
On‑site vending & gym.
Annual employee appreciation picnic.
Tuition reimbursement.
Employee referral bonus program.
Employee assistance program.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Quality Assurance
Industries Medical Equipment Manufacturing
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Apply to join
Applied Medical Technology, Inc. (AMT)
– a leading enteral device manufacturer located near Cleveland, Ohio.
Description Since 1985, AMT has been developing, designing, manufacturing, and engineering enteral device products in a state‑of‑the‑art facility. AMT’s steady growth provides job opportunities throughout Northeast Ohio while maintaining a small company culture with a global reach.
Position Summary Coordinate and manage Quality Assurance activities across all manufacturing processes. Ensure quality standards are met, communicate vital information to personnel, and support regulatory compliance.
Responsibilities
Assist in troubleshooting raw material issues and create/distribute reports.
Interpret and communicate company policies to auditors and enforce safety regulations.
Create 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) premarket notifications and product listings.
Investigate and review complaints; analyze incoming complaints for reportability; track and trend complaints; notify authorities as required; present complaint reports twice annually.
Review change orders (ECOs) to ensure compliance and notify regulatory bodies of changes.
Review QMS changes to ensure safety and effectiveness of the medical device and compliance with regulatory requirements.
Review and approve Engineering Test Protocols and Reports.
Manage complaints, testing, calibration, and training; train employees on QMS changes.
Facilitate external audits.
Review employee input on strengths and areas for improvement.
Qualifications
Four‑year engineering degree.
1–5 years related experience in a regulated environment, preferably medical device.
Proficiency with MS Office.
Familiarity with mechanical and electrical test equipment.
Knowledge of manufacturing concepts, practices, and procedures related to medical device manufacturing.
Ability to analyze and aggregate data using statistics.
Experience preferred with ISO 13485, ISO 14971, and FDA QSR for Medical Devices.
Language Skills Read, analyze, and interpret general business periodicals, professional journals, technical procedures, or government regulations; write reports, business correspondence, and procedure manuals; effectively present information and respond to questions from managers, clients, vendors, non‑engineers, and the general public.
Mathematical Skills Calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume; apply concepts of basic algebra and geometry; work with probability and statistical inference; apply fractions, percentages, ratios, and proportions to practical situations.
Reasoning Ability Solve practical problems and deal with a variety of concrete variables; interpret instructions; define problems, collect data, establish facts, and draw valid conclusions; interpret a wide variety of technical instructions in mathematical or diagram form and manage abstract and concrete variables.
Certificates, Licenses, Registrations Valid driver’s license.
Essential Job Functions
Mental: Communicate effectively, analyze complex data, interpret written materials, develop team, ensure compliance, respond to feedback, maintain positive relationships, troubleshoot and solve problems.
Physical: Hear, speak, use computer equipment; potentially operate a lathe, mill, or electrical/general hand tools; moderate noise; limited exposure to physical risk.
Knowledge, Skills, and Abilities Modern business communication, office procedures and methods; personal computer and Microsoft Office; establish priorities, work independently, and facilitate teamwork.
Equipment Used Telephones, computer, office equipment, electrical and general hand tools.
Special/Additional Requirements Background check: drug, alcohol, credit, and/or criminal.
Equal Opportunity/Affirmative Action AMT is an Equal Opportunity/Affirmative Action Employer.
Benefits
Insurance: Medical, dental, vision at first of month following 30 days of service.
Other Benefits: Hospital indemnity, critical illness, term life, long‑term disability (company paid), and others.
401(k): 100% match up to 3% of salary.
Paid Time Off (PTO): Nine paid holidays plus PTO based on length of service, starting day one.
Other Exciting Perks
Family‑oriented, positive working environment.
Discretionary yearly raises.
On‑site vending & gym.
Annual employee appreciation picnic.
Tuition reimbursement.
Employee referral bonus program.
Employee assistance program.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Quality Assurance
Industries Medical Equipment Manufacturing
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