This position is responsible to assist and conduct Quality System activities to ensure that products, materials, components are manufactured as per regulatory requirements and that quality manufacturing systems are in place using standard procedures (e.g. ISO 13485:2003, ISO 13485:2003:2016, 21 CFR part 211, 820, etc.) and to provide support and oversight to complaint handling, medical device reporting, product recalls and post market surveillance and vigilance to ensure compliance with regulatory agencies (e.g. Food and Drug Administration (FDA), Health Canada, Medicines and Healthcare Product Regulatory Agency (MHRA), ISO, etc.).
Key responsibilities include:
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Assist in CAPA related activities.
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Assist in Documentation Control activities.
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Conduct internal GMP audits.
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Monitor Nonconforming Material processing.
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Analyze and prepare periodic trend analysis which are presented during management reviews and take appropriate corrective and preventative action to ensure patient safety and compliance with regulatory reporting requirements.
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Assist during FDA, ISO 13485 or other third party inspections involving complaint handling assessments or post market vigilance activities and product recall effectiveness checks.
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Develop, implement, and update policies and procedures.
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Facilitates internal training on quality assurance requirements, processes, and procedures.
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Assist with internal calibration system for mechanical gages and tools, includes calibration of in-house equipment or processing of off site calibration.
Additional responsibilities may include:
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Assist with preparing, documenting and conducting Audits.
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Assisting with Regulatory activities.
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Assist with supplier evaluations and corrective action.
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Prepare and file Medical Device Reports (MDRs) with FDA and/or equivalent European regulatory agency.
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Other Quality/Regulatory activities as required
Amount of experience required:
5 years demonstrated experience in a QA environment or 2 year associates degree with 1 year QA experience.
Educational requirements:
Minimum High School Diploma
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Experience
Required
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5 years demonstrated experience in a QA environment or 2 year associates degree with 1 year QA experience.
Education
Required
Preferred