Quality Engineer

POSITION SUMMARY:

The Quality Engineer (QE) will be responsible for management and execution of assigned quality projects in order to meet quality assurance objectives. The QE shall have prior experience working within an FDA compliant Title 21 section 820 environment and the ability to work cross-functionally to support rapid growth and continuous improvement. This position primarily will support in-house manufacturing operations.

PRIMARY DUTIES AND RESPONSIBILITIES:

• Creates and updates quality system procedures working on cross-functional teams to align best practices, procedures, and applicable regulations (FDA, ISO, etc.)
• Evaluates product changes and directs appropriate disposition of product through the company’s change control system
• Assemble non-sterile product into kits for final release into the field
• Participate in setup, qualification, calibration, and maintenance of manufacturing and inspection equipment
• Responsible for creation of inspection models, inspection prints, gaging, or other inspection documents and detailed testing requirements to insure receipt of quality product
• Support concurrent engineering efforts by participating in design development projects representing quality assurance and the customer (supplier and end user)
• Responsible for creating and maintaining process risk management files to meet FDA and ISO standards
• Reviews product and documentation non-conformances and recommends inspection, product and/or quality system modifications
• Interfaces with supplier quality representatives concerning issues with quality assurance and assures that effective corrective action is implemented
• Assists in inspection of work-in-progress, finished parts and assemblies, kits and completion of associated paperwork for final release of product
• Assists in reviewing patient-specific instrumentation designs
• Participates in projects and help drive and build a Continuous Improvement and Lean culture across the organization

MINIMUM REQUIREMENTS:

Education and Experience: Bachelor's degree in Engineering, Science, Technology or a related discipline with 3+ years of progressive medical device engineering experience (Manufacturing, Development or Quality Engineering) within an FDA compliant Title 21 section 820 environment

All your information will be kept confidential according to EEO guidelines.

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