QMS Specialist

## QMS Specialist Apply locations:
US CO Westminster time type:
Full time posted on:
Posted 2 Days Agojob requisition :
JR100066

QMS Specialist 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 plansand 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%### About UsWelcome to the Highridge Medical's Career Page. 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.

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