Quality Management System (QMS) Specialist

Quality Management System (QMS) Specialist

About Us:

We are an innovative medical device start-up dedicated to restoring upper extremity function for stroke patients. With our new manufacturing facility qualified and production scaling up, we are seeking a Quality Management System Specialist to play a critical role in maintaining compliance and ensuring excellence in our quality management practices.

Position Overview:

The Quality Management System Specialist will lead the audit program, manage document control systems, and provide independent oversight of quality investigations and corrective actions. This role is vital in upholding our commitment to delivering high-quality medical devices while ensuring compliance with regulatory standards.

Key Responsibilities:

1. Audit Program Management:
   1. Lead the internal audit program, including QMS audits and manufacturing audits, to ensure compliance with ISO 13485 and FDA 21 CFR Part 820.
   2. Host external audits conducted by regulatory bodies and certification organizations, preparing and supporting the audit process from planning to follow-up actions.
   3. Develop and maintain audit schedules, reports, and corrective action plans to address audit findings.
2. Document Control and Training Administration:
   1. Administer the electronic quality management system (eQMS) to ensure accurate and up-to-date documentation.
   2. Oversee document control processes, including revision, approval, and distribution of controlled documents.
   3. Manage the training program within the eQMS, ensuring that employees are trained on applicable procedures and regulatory requirements.
3. Quality Oversight:
   1. Provide independent review and approval of investigations, corrective actions, and nonconformances to ensure compliance with quality standards.
   2. Monitor the effectiveness of corrective and preventive actions (CAPA) and drive continuous improvement initiatives.
   3. Collaborate with cross-functional teams to resolve quality issues and enhance processes.

Qualifications:

1. Bachelor’s degree in Engineering, Quality Management, or a related field.
2. Minimum of 5 years of experience in quality management roles, preferably within the medical device industry.
3. Strong understanding of ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements.
4. Experience with audit program management, including internal and external audits.
5. Proficiency in administering electronic quality management systems and document control.
6. Excellent analytical, organizational, and communication skills.
7. ISO Auditor certification or equivalent is a plus.

Why Join Us:

1. Opportunity to contribute to the development of life-changing medical devices.
2. Collaborative and mission-driven work environment.
3. Competitive compensation and benefits package.
4. Opportunities for professional growth and development.

Please note that the salary information is a general guideline only. Neurolutions considers factors such as the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, and internal equity, as well as location, market, and business considerations when extending an offer.