Quality Assurance Specialist

Summary

The Quality Assurance and Regulatory Affairs Specialist will play an integral role in maintaining regulatory compliance for all company products. This position collaborates with various teams, including product design, to ensure adherence to current regulatory standards and correct product labeling. The Specialist also works closely with the Quality Department to uphold compliance within Quality Management System processes and risk documentation.

Key Responsibilities

• Verify that products and processes comply with ISO 13485, FDA Quality System Regulation (QSR), Medical Device Directive (MDD), Therapeutic Products Export Data (TPED), Medical Device Single Audit Program (MDSAP), and related standards by reviewing and approving Engineering Change Orders in line with design control rules.
• Oversee the Corrective and Preventive Action (CAPA) program by monitoring CAPA progress via MasterControl software, organizing meetings to confirm root causes and effective remedial solutions, and striving to enhance CAPA resolution speed.
• Manage customer complaint investigations from review to closure, including issuing reports to customers as necessary.
• Support audits by third parties, notified bodies, and regulatory agencies. Participate in internal audit teams when required.
• Conduct routine audits of critical suppliers to ensure ongoing compliance as mandated by notified bodies, preparing audit schedules and optimizing travel plans to minimize costs.
• Administer software management tasks, ensuring that updates and new versions are correctly validated, including involvement in software validation processes and the MyCAIRE application.
• Engage in Regulatory Team meetings, taking on extra projects and responsibilities as assigned.

Competencies

• Strong ethical standards in business practices
• Effective communication abilities both written and verbal
• Presentation and interpersonal skills
• Collaborative mindset and teamwork orientation
• Project management expertise
• Technical proficiency in quality and regulatory standards

Work Environment and Physical Requirements

This role is based onsite at the Ball Ground, GA headquarters, blending professional office and manufacturing/distribution settings. While largely sedentary, the role may occasionally require physical activities such as lifting, bending, or standing.

Travel

The position involves travel up to 15%, which may include international trips.

Required Education and Experience

• Bachelor’s degree, preferably in engineering or a technical field
• Minimum of three years of relevant experience
• Familiarity with ISO 13485, FDA QSR, MDD, MDSAP, and other applicable codes and standards
• Knowledge of the European Union Medical Device Regulation (EU MDR 2017/745)
• Strong communication skills at all organizational levels
• Demonstrated capability in cross-functional teamwork and managing projects
• Proven aptitude for planning and handling multiple assignments concurrently

Preferred Qualifications

• Master’s degree or MBA
• Relevant industry certifications
• Experience with US FDA 510(k) submissions
• Knowledge of software product regulatory approvals

Additional Information

No additional eligibility requirements apply. Responsibilities may evolve as business needs change. The company is dedicated to providing reasonable accommodations for qualified individuals with disabilities to fulfill essential job functions. Equal employment opportunity is offered without discrimination based on legally protected characteristics.