QMS Specialist

Highridge Medical; Westminster (CO); On-site; USD 90,000 - 120,000; Full time

Job summary

Highridge Medical seeks a Quality Management System Specialist to ensure the organization’s QMS complies with ISO 13485, FDA 21 CFR Part 820, EU MDR, and GMP. The role administers eQMS related to CAPAs and NCs, drives CAPA activities including trending, and supports audits and regulatory inspections to maintain patient safety and product quality.

The position leads CAPA programs, trains staff on CAPA processes, and coordinates health hazard evaluation and field action programs.

Qualifications

• Bachelor’s degree in a technical discipline or equivalent with quality certification preferred.
• Experience with Medical Device or pharmaceutical quality systems and regulatory requirements.

Responsibilities

• Implement and maintain the CAPA program and related software.
• Monitor CAPA metrics, root cause analysis and action plans with timely closure.
• Coordinate CAPA investigations, action plans and verification activities.
• Lead CAPA meetings and maintain CAPA files and training materials.
• Support audits, regulatory inspections and post-market activities.
• Drive health hazard evaluation and field action processes.
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR and GMP.

Skills

CAPA oversight

Regulatory compliance

Quality systems knowledge

Root cause analysis

Communication skills

Time management

Training and mentoring

Problem solving

Education

Bachelor’s degree in a technical discipline

Quality discipline certification (CQE, CQA, etc)

Tools

MS Office (PowerPoint, Excel)

Job description

Seeking a highly skilled Quality Management System Specialist who is responsible for ensuring the organization's Quality Management System (QMS) complies with global regulatory requirements, including ISO 13485, FDA 21 CFR Part 820, EU MDR, and applicable Good Manufacturing Practices (GMP). This role administers electronic Quality Management Systems (eQMS) related to CAPAs and NCs, drives corrective and preventive action (CAPA) activities, including trending, supports audits and regulatory inspections, and drives continuous improvement initiatives to ensure product quality, patient safety, and regulatory compliance. In addition, the position drives the Health Hazard Evaluation Program to ensure timely evaluation of risk associated with products outside of the organization’s control to make timely field action decisions.

Principal Duties and Responsibilities

Material Documentation Support and Testing

• 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 (i.e., knowledge, skills and abilities)

• 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%

Highridge is currently unable to offer sponsorships now or in the future