This is Rohith from Intellectt INC; we've got an important role Manufacturing Quality Engineer - Raynham, MA with one of our prestigious clients. Interested candidates can please send your updated resume at

Job Title: Manufacturing Quality Engineer
Location: Raynham, MA
Duration: Long-term

Job Description:

• Revises / analyses 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 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