Department: Product Life cycle Management/Validation

The Quality Engineer is responsible for ensuring the product Life cycle/supply chain provides components, assemblies, and products that meet expected quality levels. The Quality Engineer works cross functionally with Operations, Engineering, and Quality Organizations, to continuously improve supplier performance by implementing process controls and develop quality assurance plans.

Responsibilities:

• Plan, develops, and executes process and test method validations (IQ, OQ, PQ, PPQ) in accordance with company and guidelines
• Responsible for practicing and assisting in ensuring company wide compliance with the Quality System procedures and requirements and lead the development of quality plans, CAPAs, supplier qualifications and support verification and validations
• Creation of Electronic Change Controls (ECOs) of Drawing, IPRs, Work instruction for initial release or doc updated Revision.
• Provide an on floor support for Inspection method records, GD & T issues in Blueprints, BOM Issues, Supplier Inspection Issues.
• Provides support on CAPA for high risk (Directly Impacted) issues.
• Coordinate inspection related activities in support of other departments’ functions and requirements including performing inspections or tests of purchased parts. Coordinate the reporting, analysis, and resolution of material non-conformance incidences including active participation in Material Review Board and other meetings as needed. Support and coordinate supplier related quality activities to ensure continued improvement. Perform inspections or tests of
• Adhere to design control procedures, general safety rules, company policies and procedures, Good Manufacturing Practices, and FDA regulations including the qualification and implementation of Document Changes Notices involving product or process changes.
• Manage the Complaint System including completion of product evaluations and investigations, ensure Complaints are evaluated and closed in a sufficient manner
• Monitor and support calibration and maintenance of all test equipment and fixtures and operation of equipment. Serve as coordinator for Calibration system. This includes issuing Purchase orders, maintaining Calibration log, coordinating calibration activities, reviewing certifications and updating calibration log.
• Conduct quality audits and develop subsequent preventive action programs, including appraisal and approval or disapproval of suppliers.

Educational and/or experience requirements:

• Bachelor’s or higher degree in Industrial / Pharmaceutical Engineering or related field
• Knowledge of Quality Systems Manual, Documentation System; QSR, MDD, CMDR, ISO14971, ISO13485:2003
• Working knowledge of ISO and applicable customer and regulatory standards
• Good Understanding of IQ/OQ/PQ/PPQ

Job Type: Full-time

Salary: $65,000.00 to $75,000.00 /year

Please send profile at info@zenithlifescience.com for direct consideration or question.

• Posted on 07/18/2022