This is Shashank from Intellectt INC.We have an immediate opportunity. Please find the below job description and if you are interested, please forward your resume to shashank@intellectt.com or call me on 732-719-2427.
Job Title: Manufacturing Quality Engineer
Location: Raynham , MA (Onsite)
Duration: 12 Months+
Job Description
Revises / analyzes if the current products and processes (including taken actions or decisions) comply with the regulations, such as QSRs, ISO 13485, etc. including providing support during internal and external audits.
Participates in the preparation's activities for/or interactions with regulatory agencies (FDA, JJRC, BSI, etc.).
Responds to internal or external audit observations related to the quality engineering function.
Properly establishes and maintains the required documentation of quality assurance activities and/or quality systems.
Performs periodical audits to the line to evaluate GMPs, production controls, lot segregation and process audit according to JJPS. Checks the audit results of the area to ensure that the corrective and preventive actions are adequate.
Works with NPI and with the manufacturing, process engineering and manufacturing engineering departments to develop, conduct and approve product and process validation strategies of products and processes.
Directs and attends to NCs Revisions meetings as a member of MRB.
Conducts and supports investigations, bounding, documentation, revision and approval of the non-conformities (NCs), preventive and corrective actions
Seniority level
Entry level
Employment type
Full-time
Job function
Engineering and Information Technology
Industries
Human Resources Services
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