Manufacturing Associate - 2nd or 3rd Shift

About the role

This position is responsible for the production of quality medical devices. It supports Production and Logistics by performing and documenting daily manufacturing operations that involve operating various process equipment and other tasks in support of the production schedule.

Responsibilities

• Perform the daily manufacturing steps required to produce medical devices.
• Maintain the integrity of ISO class 7 & 8 Cleanrooms by performing proper gowning, entry and cleaning procedures.
• Perform in-process quality checks on sub assemblies and finished products.
• Responsible for inspection, labeling, packaging and shipping and final products.
• Perform daily equipment checks and preventive maintenance per established procedures.
• Utilize small hand tools, calibrated instruments, measurement equipment, and test fixtures.
• Perform cleaning of equipment, labware and manufacturing areas in accordance with SOPs.
• Maintain raw material inventory and perform incoming inspections.
• Aid in ongoing process improvement and subsequent validation activities.
• Participate in line and production planning meetings as needed.
• Work with engineers, technicians and management to resolve line issues and suggest improvements.
• Maintain accurate records and documentation related to quality, work in progress, test results and special projects.
• May interact with external customer contacts including participating in tours for visitors including VIPs and may be questioned and/or observed during audits.
• Adhere to general safety rules, manufacturing procedures, company policies and procedures, ISO and FDA regulations.

Requirements

Experience working with laboratory chemicals and equipment including pipettes, balances, sealers, and vacuum ovens. Ability to follow SOPs, work instructions, and maintain daily records in a timely and reliable fashion. Must be highly organized individual who works independently with minimum supervision in a fast-paced environment. Must have a high level of hand-eye coordination. Excellent communication skills both written and verbal. Comfortable working under an ISO 13485 or 9001 Quality Management System.

Qualifications

• High school diploma or equivalent
• Minimum 2 years working in a manufacturing environment, preferably within the medical device or tissue banking industry.
• Minimum 2 years working with an electronic manufacturing and inventory system such as Fishbowl or SAP.