AirClean Systems
Position Summary
This person will be involved with coordinating and managing the Quality Assurance activities in all areas of the production/manufacturing processes. This will consist of ensuring quality standards are met in the manufacturing of products. The person must be able to effectively communicate vital information to various personnel throughout the organization.
Duties and Responsibilities
Assist in troubleshooting raw material issues, determine best course of action and distribute reports.
Interpret and communicate company policies to auditors and enforce safety regulations.
Create and modify regulatory procedures to comply 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, review, analyze and track complaints; notify proper authorities; create annual complaint reports.
Review ECOs and QMS changes for regulatory compliance; approve Engineering Test Protocols and Reports.
Manage complaints, testing, calibration, training and facilitate external audits.
Train employees on QMS changes and give input on strengths and improvement areas.
Minimum 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 medical device manufacturing concepts, practices and procedures.
Ability to analyze and aggregate data using statistics.
Experience with ISO 13485, ISO 14971 and FDA QSR (preferred).
Benefits
Medical, dental and vision insurance (full coverage after 30 days).
Other voluntary benefits: hospital indemnity, critical illness, term life and long‑term disability.
401(k) with 100% match up to 3% of salary.
Paid time off (nine paid holidays plus PTO based on length of service).
AMT is an Equal Opportunity/Affirmative Action Employer.
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Duties and Responsibilities
Assist in troubleshooting raw material issues, determine best course of action and distribute reports.
Interpret and communicate company policies to auditors and enforce safety regulations.
Create and modify regulatory procedures to comply 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, review, analyze and track complaints; notify proper authorities; create annual complaint reports.
Review ECOs and QMS changes for regulatory compliance; approve Engineering Test Protocols and Reports.
Manage complaints, testing, calibration, training and facilitate external audits.
Train employees on QMS changes and give input on strengths and improvement areas.
Minimum 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 medical device manufacturing concepts, practices and procedures.
Ability to analyze and aggregate data using statistics.
Experience with ISO 13485, ISO 14971 and FDA QSR (preferred).
Benefits
Medical, dental and vision insurance (full coverage after 30 days).
Other voluntary benefits: hospital indemnity, critical illness, term life and long‑term disability.
401(k) with 100% match up to 3% of salary.
Paid time off (nine paid holidays plus PTO based on length of service).
AMT is an Equal Opportunity/Affirmative Action Employer.
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