QMS Specialist

HIGHRIDGE Inc.; Westminster (CO); On-site; USD 70,000 - 90,000; Full time

Job summary

HIGHRIDGE Inc. is seeking a QMS Specialist to implement and maintain quality systems in Westminster, Colorado. The role involves managing the CAPA program, coordinating training, and ensuring compliance with regulatory standards. Ideal candidates will have a Bachelor's degree and 3+ years of experience in the medical device or pharmaceutical field.

In addition, the position requires strong communication skills and a detail-oriented approach to quality management. Occasional travel (up to 10%) is expected.

Qualifications

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

Responsibilities

• Implement and maintain the CAPA program.
• Coordinate CAPA meetings and monitor effectiveness.
• Communicate with regulatory agencies on field actions.
• Prepare corrective action plans for audits.

Skills

Detail oriented

Excellent time management

Quality control techniques

Effective communication

Problem-solving techniques

Education

Bachelor’s degree in a technical discipline

Certification in a Quality discipline (e.g. CQE, CQA)

Tools

Microsoft Excel

Microsoft PowerPoint

Job description

## QMS SpecialistApplylocations: US CO Westminstertime type: Full timeposted on: Posted 2 Days Agojob requisition id: JR100066QMS SpecialistPrincipal Duties and ResponsibilitiesMaterial 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 RequirementsThe 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. For additional information, please visit www.highridgemedical.com.