QMS Specialist

Highridge Medical•Westminster, CO

6d•Remote

About The Position

Highridge Medical is committed to improving spine care by partnering with the surgeon community to drive innovation. The company has a compelling and comprehensive portfolio supported by extensive clinical evidence, including solutions for complex spine, motion preservation, minimally invasive surgery, biologics, and enabling technologies. The QMS Specialist will play a key role in maintaining and improving the quality management system, focusing on CAPA, Health Hazard Evaluations, and supporting various quality system functions.

Requirements

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.

Nice To Haves

Medical Device regulations experience preferred.

Responsibilities

Implement and maintain the CAPA program including software solutions.
Monitor 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.
Communicate 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.