Quality Manager

AuST Manufacturing is a rapidly growing medical device design house and manufacturing facility, with an innovative and energetic team committed to improving patient outcomes through high-quality products and cutting-edge technology. We are committed to maintaining the highest standards of quality and compliance in all our operations.

The Quality Manager will oversee and manage the quality assurance processes within the company. This role is critical in ensuring that all products meet regulatory requirements and industry standards, and that the company maintains compliance with ISO 13485 and other relevant regulations.

Key Responsibilities:

· QMS Progression- Continuously improve the Quality Management System (QMS) in accordance with ISO 13485, other applicable standards, and best practices.

· Leadership - Manage and mentor the compliance team, ensuring effective performance and professional development.

· Collaboration - Collaborate effectively with cross-functional teams to ensure compliance and continuous improvement, fostering a supportive and cooperative environment rather than a policing role, and to instill a culture of quality within the organization.

· Audit - Lead internal and external audits to maintain ISO 13485, MDSAP, and MDR certifications and compliance.

· Supplier Quality - Oversee supplier quality management, including supplier audits, qualification, and performance monitoring.

· NCR/CAPA - Manage the nonconforming material control and CAPA (Corrective and Preventive Action) processes, including investigation, root cause analysis, and implementation of corrective actions.

· Training - Develop and implement training programs to educate personnel on GMP/GDP best practices, regulatory requirements and company standards.

· Batch Record Review - Oversee the batch record review process.

· KPIs/Quality Metrics - Monitor key quality performance indicators (KPIs) to track the effectiveness of the Quality Management System (QMS) and to identify areas of improvement.

· Complaints - Manage customer complaints, ensuring thorough investigation, resolution, and documentation in compliance with regulatory requirements.

· Document Control - Ensure proper documentation control and record-keeping in compliance with regulatory requirements. Administrate ECOs and post-implementation actions.

Qualifications:

· Bachelor’s degree in a scientific discipline.

· Minimum of 5 years of experience in quality management within the medical device industry.

· In-depth knowledge of ISO 13485, FDA regulations, and other relevant standards.

· Strong analytical and problem-solving skills.

· Excellent communication and leadership abilities.

· Experience with quality management software and tools.

· Ability to adapt quickly, make risk-based decisions, and to succeed in a fast-paced environment.

· Certification in quality management (e.g., CQE, CQA) is a plus.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Ability to Commute:

• West Valley City, UT 84119 (Preferred)

Ability to Relocate:

• West Valley City, UT 84119: Relocate before starting work (Preferred)

Work Location: In person