Quality Systems & Training Coordinator

Orchid Orthopedic Solutions LLC; Farmington Hills (MI); Presencial; USD 52.000 - 80.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Performance bonuses

Medical benefits

401(k) with company match

Paid time off

Descripción de la vacante

Orchid Orthopedic Solutions LLC in Farmington Hills, MI seeks a Quality Coordinator to ensure quality systems compliance, training completion, and document control. You will calibrate equipment, support audits, and collaborate with cross-functional teams to meet FDA guidelines and drive continuous improvement.

The role requires high school level education, 3+ years in quality-related work in regulated industries, and strong attention to detail.

Formación

• Accuracy and Attention to Detail - Working Experience
• Data Analysis Tools - Working Experience
• ISO 9001 (Quality Management) - Basic Knowledge
• Organization - Basic Knowledge
• Computer Knowledge - Working Experience

Responsabilidades

• Lead Document Control activities, including updating controlled documents, forms, procedures, work instructions, policies; final release of Engineering Change Orders; maintenance of document logs
• Support training programs and ensure they meet regulatory and company requirements
• Support process monitoring by conducting sample collection for production utilities (air, water, cleanline monitoring, tension testing, abrasion testing)
• Inspects parts using precision measuring equipment
• Collaborate with Sustaining Product Quality and NPI groups on quality planning such as FAR's, FIF's
• Assist the quality team on the implementation, training and use of precision measuring equipment
• Coordinate with customers when measurement system analysis is required
• Perform daily/weekly/monthly calibration of measuring equipment (excluding handheld gages)
• Advise on compliance requirements and regulations
• Track and trend quality metrics
• Assist in internal and/or customer audits
• Collaborate with suppliers on quality and process improvements
• Assist with establishing procedures/work instructions to meet FDA guidelines
• Read/interprt customer drawings to develop Quality Inspection Plans and related documents
• Participate on cross-functional project teams
• Assist engineers with part fixtures for inspection
• Work with customer and QC to determine dimensional and cosmetic acceptance criteria and methods

Educación

High School Or Equivalent

Descripción del empleo

Orchid Orthopedic Solutions LLC in Farmington Hills, MI seeks a Quality Coordinator to ensure quality systems compliance, training completion, and document control. You will calibrate equipment, support audits, and collaborate with cross-functional teams to meet FDA guidelines and drive continuous improvement.

The role requires high school level education, 3+ years in quality-related work in regulated industries, and strong attention to detail.