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 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%