Job Description
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. The ideal candidate will have a strong background in medical device quality systems and regulatory requirements, with a proven ability to collaborate cross-functionally and present to leadership to ensure the highest level of quality assurance across the organization.
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.
Documentation & Reporting
- Ensure proper documentation and records management following Internal SOP and global regulatory requirements.
- Writes and revises SOPs, WI, controlled forms, and related documents to ensure best practices and alignment with current operations.
- Generate reports for management highlighting QMS health, product safety and performance, audit results, and regulatory compliance.
- Maintains data 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.
- Assist with any other duties as assigned.
Knowledge, Skills, and Abilities
Knowledge/Skills
- Strong knowledge of medical device quality management systems and regulatory requirements.
- Experience leading cross-functional teams to drive quality improvements.
- Excellent problem-solving skills and ability to perform root cause analysis.
- Strong written and verbal communication skills, with the ability to effectively communicate with internal teams and regulatory agencies.
- Proficient in the use of QMS software and tools (e.g., MasterControl, Veeva, etc.).
Personal Attributes
- Detail-oriented with strong organizational and project management skills.
- Ability to work independently and as part of a team in a fast-paced environment.
- Strong analytical and critical thinking skills.
- Proactive, with a strong drive for continuous improvement and quality excellence.
Qualifications
Education
- Bachelor of Science degree, preferably in Engineering, Nursing, or other science field.
- Relevant certifications (e.g. CQE, CQA, or similar) preferred.
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.
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