Quality Coordinator – Medical Devices QA & Compliance

Orchid; Detroit (MI); On-site; USD 52,000 - 68,000; Full time

Job summary

Orchid, a growing orthopedics company in Farmington Hills, MI, seeks a Quality Coordinator to maintain quality systems and ensure regulatory compliance. The role emphasizes document control, training support, and calibration activities within a highly regulated medical devices environment.

The ideal candidate has a high school diploma or equivalent, 3+ years in quality systems, and familiarity with FDA guidelines.

Qualifications

• High school diploma or equivalent required.
• Experience in quality-related work required.
• 3+ years in quality systems in regulated industries preferred.
• Knowledge of FDA guidelines and quality systems.

Responsibilities

• Lead Document Control activities, updating controlled documents and release of Engineering Change Orders.
• Support training programs to meet regulatory and company requirements.
• Assist calibration and inspection activities with precision measuring equipment.
• Coordinate quality planning with FARs, FIFs, and quality initiatives.
• Support measurement system analysis with customers as needed.
• Assist internal and supplier audits and non-conformity investigations.

Skills

Attention to detail

Data analysis

ISO 9001 knowledge

Organization

Computer skills

Education

High School Diploma or Equivalent

Job description

Orchid, a growing orthopedics company in Farmington Hills, MI, seeks a Quality Coordinator to maintain quality systems and ensure regulatory compliance. The role emphasizes document control, training support, and calibration activities within a highly regulated medical devices environment.

The ideal candidate has a high school diploma or equivalent, 3+ years in quality systems, and familiarity with FDA guidelines.