Job Description

Director Quality Assurance

Summary/Objective

The Director of Quality Assurance is a key member of the QARA team, responsible to ensure effectiveness and compliance of the Quality Management System (QMS) with applicable standards and regulations. The Director of Quality Assurance will perform duties as the Quality Management Representative. They may also perform certain specified duties in the role of Person Responsible for Regulatory Compliance for CAIRE Inc. This position will lead a team and work with cross-functional teams and 3rd party test labs to ensure completion of product testing required for global approvals and licensing.

The Director will oversee Design Quality, Product Quality, and QMS management teams, including staff responsible for maintaining the electronic QMS software and document control utilizing MasterControl software. The QMS covers domestic locations in Georgia and New York, as well as a manufacturing site in Chengdu, China, and Service & Repair centers in the US and EU (Langenfeld, Germany and Padova, Italy). This team leader will also provide mentoring, leadership, and development of their direct reports.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ensure product/process compliance with the requirements of applicable standards and regulations including ISO 13485, ISO 9001, FDA QSR, MDD/MDR, PED/TPED, MDSAP, and country-specific requirements.
• Assist in the review and implementation of internal quality procedures to ensure QMS compliance is maintained or enhanced.
• Proactively maintain existing QMS certifications, striving for continuous improvement.
• Work with Engineering on new product releases and changes to existing products, including assessment of required testing, verification & validation efforts, labeling and design transfer activities.
• Manage and maintain product risk management files based on regulatory (e.g. ISO 14971, MDR, TPED, and PED, etc.) and post-market requirements.
• Work with Design and Development Project teams to ensure compliance with Design Control procedures.
• Oversee the Quality Management System functions including Internal Audit program, CAPA program, Engineering change controls, Post-Market Surveillance, Vigilance, Document Control, Continual Improvement and other functions as QMS Management Representative.
• Establish, monitor and report on quality metrics, reviewed in monthly Quality Review meetings
• Conduct annual Management Review meetings.
• With the Director RA, coordinate and facilitate 3rd party external audits.
• Review customer contracts and supplier quality agreements for QMS compliance.
• Keep up to date on applicable standards/new standards and communicate changes throughout the company.
• Monitor QMS risk and product risk for significant changes to ensure continued compliance
• Maintain the Quality Assurance budget within approved annual spending.
• Ensure compliance to training programs in the business unit and satellite facilities to ensure personnel are familiar with and knowledgeable regarding QMS processes and requirements.

Competencies/Success Factors

• Detail Orientation / Quality Focus
• Adaptability / Flexibility
• Results Focus / Output Orientation
• Handling Conflict or Difficult People
• Ethics, Integrity, Values
• Coaching / Developing Others
• Change Management
• Leadership

Supervisory Responsibility

This position will supervise Quality Assurance staff both locally and remotely, as well as in domestic and international locations.

Work Environment

This job operates in a professional office environment and manufacturing/distribution environment. The role is expected to be in-person at the corporate headquarters and manufacturing facility, located near Canton, Georgia.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. This is largely a sedentary role; however, some activity is required. This would require the ability to lift, bend or stand as necessary.

Travel

This position requires up to 20% travel. Some of the travel may be international.

Required Education and Experience

• Bachelors degree from a four-year college or university, preferably an engineering or technical degree
• 10+ years of medical device experience required
• 5+ years of team leadership experience required
• Experience with various Codes and Standards (ISO 13485, FDA QSR, MDR, MDSAP, etc.) required
• Working knowledge of EU MDR (2017/745)
• Experience and working knowledge with international QMS requirements
• Good communication skills at all levels (written and verbal)
• Proven ability to work with cross-functional teams and in a project management environment
• Demonstrated ability to plan and manage multiple tasks/projects

Preferred Education and Experience

• MBA or masters degree.
• Related certifications commensurate with the role.
• Change management experience is preferred

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