Quality Specialist

Medix is currently hiring for a Quality Specialist to join a medical device packaging and distribution team that we partner with in Santa Maria, CA! In this role, you'd have the opportunity to work directly with the Quality Manager to ensure that Quality standards are met or exceeded in all facets of the site operation.

ESSENTIAL DUTIES:

• Assist site's Quality Manager to ensure compliance with all quality and regulatory guidelines.
• Help manage and ensure outstanding Quality System performance via monitoring and measuring of process performance.
• Drive any appropriate action, including issuing and follow-up on Corrective/Preventive Actions (CAPAs) and Material Review Boards (MRBs).
• Perform assigned tasks including, but not limited to, inspection and product release, label approval, calibration, warehousing controls, record retention, document control, training, control of non-conforming product, investigation of product complaints.
• Host and manage internal and external audits.
• Successfully deploy and support change management and appropriate training plans.
• Assist with managing document control functions and change control system.
• Manage the complaint handling system, including trending and review to identify opportunities for improvement.
• Prepares training materials and performs on-site training on relevant GMP topics for staff and new hires.

MINIMUM QUALIFICATIONS:

Training and Experience

• Associate's degree (or above).
• 2 years of relevant experience in a medical device or pharmaceutical company preferred.

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