Quality Assurance Engineer III

Responsibilities: This position is responsible for the Change/Risk Management program at the Fair Lawn and Bridgewater sites. This key technical role is responsible for the review, approval and issuance of applicable customer notices, as applicable, of change requests in support of the systems and product at the NJ LCD sites in line with ISO 9001:2015 and applicable GMP regulations. Key activities of this role include: Review and approval of Product Management Requests (PMRs) and Site Management of Change (MOCs) Requests to ensure proper impact assessment of change has been performed and all supportive documentation for the change is submitted to support the request Logging and Issuance of Change requests to impacted areas for completion of tasks Tracking of task completion to ensure closure of change required deliverables Drafting and Issuance of all Customer Notifications as required Review of equipment related change requests to ensure proper documentation and submission of closure Act as SME for Change Management activities and inquiries during site inspections Support and perform Risk Based assessments for projects and management determination Assures that all changes are in line with local Quality System (QS), FDA Quality System Regulation (QSR) (as applicable) and International Standards Organization (ISO) regulations Participates in PPI / Kaizen events as key Quality SME. Partners with the senior Quality management and Operations leads for implementation of quality system improvements needed to be support the Change Management program at the local site. Qualifications: Bachelor's degree in Biological Sciences, Engineering or related field, or equivalent combination of education and work-related experience. Must have experience with Change Management programs and impact assessment of change in a regulated industry, such as Pharmaceutical and/or Medical Device. Significant risk management expertise is required. 8+ years relevant industry experience. Knowledge of US and International regulations and standards that apply to the medical device industry including FDA Quality Systems Regulations (21 CFR 820), Medical Device Reporting (21 CFR 803) Corrections and Removals (21 CFR 806), MDR/IVDR, 13485:2016, ISO 9001: 2015. Must demonstrate effective influencing and change management skills and demonstrated achievements in process improvements. Excellent communication skills at all levels both written and verbal. 83677BR
Salary Range: NA
Minimum Qualification
8 - 10 years

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