QMS Specialist

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

QMS Specialist Principal Duties and Responsibilities

• Implement and maintain the CAPA program including software solutions.
• Duties include, but are not limited to, monitoring of information relative to problem statements, root cause analysis, corrections, corrective and preventative actions, tracking of timelines, and establishing CAPA files.
• Assist/Interface with CAPA owners on CAPA Investigations, Action Plans, and Verification/Validation Activities to drive timely completion of CAPA activities.
• Coordinate CAPA meetings, establish meeting times, locations, agenda, and maintain meeting minutes.
• Monitor the suitability and effectiveness of the CAPA system. Identify appropriate metrics and trend CAPA metrics and present defined reports at specified intervals to CAPA Committee and Management Review.
• Maintain and revise applicable quality systems interfacing with CAPA.
• Serve as a resident expert in CAPA regulatory/compliance and coach/mentor employees.
• Coordinate training for users of CAPA system and develop assorted training materials.
• Conduct training on root cause investigation and problem-solving techniques.
• Serve as the resident expert for the Health Hazard Evaluation program and train team members on the process that aligns with regulatory requirements.
• Lead and maintain the HHE and Field Action programs.
• Communicates with appropriate regulatory agencies on field action activities and monitor progress until field action closure.
• Perform various activities including support of internal audit program, document control, and post market activities, and regulatory inspections, and notified body audits.
• Participate in audit response activities, including preparation of corrective action plans and closure of audit findings.
• Monitor regulatory changes and assess their impact on quality systems and procedures.

Expected Areas of Competence

• Familiar with aspects and elements of quality systems, including but not limited to, CAPA, management responsibility, product realization and measurement, analysis and improvement process.
• Knowledge of all aspects of modern quality control/assurance techniques such as, corrective/preventative action plans, and root cause analysis.
• Detail oriented with excellent time management and organization skills.
• Familiarity with computer usage and application such as Microsoft Applications such as: PowerPoint, Excel, etc.
• Reliable and capable of working with minimal supervision to manage assigned tasks and follow up activities.
• Innovative with the ability to make sound suggestions for improvement.
• Possess effective communication skills both oral and written.
• Highly compliance oriented to firmly adhere to principles of regulation and standards.
• Must possess strong communication skills for Interactions with internal and external customers.

Education/Experience Requirements

• Bachelor’s degree in a technical discipline or an alternative Bachelor’s degree program with certification in a Quality discipline (e.g. CQE, CQA, etc).
• Medical Device regulations experience preferred.
• 3+ years of experience or equivalent combination of education and experience in medical device, or pharmaceutical field.

Travel Requirements

The role will require occasional travel up to 10%.