Quality Systems Specialist III

Job Summary

The Quality Systems Specialist III will play a pivotal role in maintaining and enhancing our QMS to ensure compliance with ISO 13485, FDA, EU MDR regulations, and other applicable international standards. This position will be responsible for measuring effectiveness and leading the continuous improvement of the QMS, ensuring effective corrective and preventive actions (CAPAs), and helping lead internal and external audits and regulatory inspections.

Responsibilities

• QMS Management & Improvement

• Oversee the day-to-day management of the company’s Quality Management System (QMS) to ensure compliance with internal/external procedures, standards, and global regulations including but not limited to FDA 21 CFR Part 820, ISO 13485, and EU MDR.
• Lead the Quality Management Review (QMR) process by scheduling meetings, collecting required data, preparing a slide deck, and scribing notes.
• Lead initiatives for the continuous improvement of the QMS, identifying areas for improvement and developing strategies to enhance overall system effectiveness and efficiency.
• Writes and revises SOPs, controlled forms, and related documents to ensure best practices and alignment with current operations.

• Regulatory Compliance & Audits

• Coordinate and prepare for internal and external regulatory inspections and audits (ISO 13485, FDA, Notified Body, Competent Authorities, etc.).
• Set up and lead backroom activities to provide necessary documentation and responses to questions arising from external audits.
• Develop and manage audit schedules and lead audit follow-ups to ensure corrective actions are completed in a timely and effective manner.
• Document all documentation and reports on performance metrics.

• CAPA & Non-Conformance Management

• Lead and manage the Corrective and Preventive Action (CAPA), ensuring timely processing of records including initiation, investigation/root cause analysis, and verification of implementation of effective solutions.
• Work closely with issue identifiers and owners to assess whether new product or quality system issues will escalate to CAPA.
• Guide CAPA owners through the CAPA process and support the completion of quality records.
• Manage the non-conformance reporting process, ensuring proper documentation, investigation, and resolution of product quality issues.

• Cross-functional Collaboration and Support

• Work closely with a cross-functional team including R&D, Manufacturing, Regulatory, and Supply Chain, to ensure QMS compliance and resolve quality-related issues.
• Provide subject matter expertise to cross-functional teams on QMS processes, regulatory requirements, and industry best practices.
• Comply with all company policies and procedures.
• Avoid any other duties as assigned.

Qualifications

• Education

• Bachelor of Science degree, preferably in Engineering, Nursing, or other science field.

• Relevant certifications (e.g. CQE, CQA, or similar)

• Experience

• Minimum of 5 years of experience in Quality Assurance, with at least 3 years specifically in QMS management within the medical device industry.
• In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, ISO 14971, EU MDR, and other relevant regulatory standards.
• Proven experience in managing audits, CAPA processes, and regulatory inspections.

Pay

The base salary for this position is expected to be between $75,000.00 and $91,000.00 annually. However, actual base salary if hired will be determined on an individualized basis and will be based on non-discriminatory factors, including as to individual skills, education, experience and market location.

Benefits and Rewards

• Health, dental, and vision insurance

• 401(k) plan plus employer contribution and match

• Generous paid leaves such as vacation and sick leave, including paid volunteer time

About Inogen

Inogen is an Equal Employment Opportunity/Affirmative Action Employer - Underrepresented racial and ethnic groups/Females/Individuals with Disabilities/Protected Veterans.