CAPA & QMS Specialist - Medical Devices

Highridge Medical LLC; Westminster (CO); On-site; USD 70,000 - 90,000; Full time

Job summary

Highridge Medical LLC in Westminster, Colorado is hiring a QMS Specialist responsible for implementing and maintaining the CAPA program. The role includes monitoring quality systems, driving timely CAPA completion, and providing training on regulatory procedures.

The ideal candidate will have a Bachelor’s degree in a related field, 3+ years of experience within the medical device or pharmaceutical sector, and strong communication skills. Occasional travel up to 10% may be required.

Qualifications

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

Responsibilities

• Implement and maintain the CAPA program.
• Drive timely completion of CAPA activities.
• Conduct training on root cause investigation techniques.

Skills

Quality control/assurance techniques

Corrective/preventative action plans

Root cause analysis

Effective communication skills

Detail-oriented

Time management

Organizational skills

Education

Bachelor’s degree in a technical discipline

Certification in a Quality discipline

Tools

Microsoft PowerPoint

Microsoft Excel

Job description

Highridge Medical LLC in Westminster, Colorado is hiring a QMS Specialist responsible for implementing and maintaining the CAPA program. The role includes monitoring quality systems, driving timely CAPA completion, and providing training on regulatory procedures.

The ideal candidate will have a Bachelor’s degree in a related field, 3+ years of experience within the medical device or pharmaceutical sector, and strong communication skills. Occasional travel up to 10% may be required.