CAPA & Quality Systems Specialist – Medical Devices

HIGHRIDGE Inc.; Westminster (CO); On-site; USD 70,000 - 90,000; Full time

Job summary

HIGHRIDGE Inc. is seeking a QMS Specialist to implement and maintain quality systems in Westminster, Colorado. The role involves managing the CAPA program, coordinating training, and ensuring compliance with regulatory standards. Ideal candidates will have a Bachelor's degree and 3+ years of experience in the medical device or pharmaceutical field.

In addition, the position requires strong communication skills and a detail-oriented approach to quality management. Occasional travel (up to 10%) is expected.

Qualifications

• 3+ years in medical device or pharmaceutical field.
• Experience with medical device regulations preferred.
• Knowledge of CAPA and quality systems.

Responsibilities

• Implement and maintain the CAPA program.
• Coordinate CAPA meetings and monitor effectiveness.
• Communicate with regulatory agencies on field actions.
• Prepare corrective action plans for audits.

Skills

Detail oriented

Excellent time management

Quality control techniques

Effective communication

Problem-solving techniques

Education

Bachelor’s degree in a technical discipline

Certification in a Quality discipline (e.g. CQE, CQA)

Tools

Microsoft Excel

Microsoft PowerPoint

Job description

HIGHRIDGE Inc. is seeking a QMS Specialist to implement and maintain quality systems in Westminster, Colorado. The role involves managing the CAPA program, coordinating training, and ensuring compliance with regulatory standards. Ideal candidates will have a Bachelor's degree and 3+ years of experience in the medical device or pharmaceutical field.

In addition, the position requires strong communication skills and a detail-oriented approach to quality management. Occasional travel (up to 10%) is expected.