The Quality Supervisor will lead and maintain our Quality Management System (QMS) in compliance with ISO 13485:2016 standards. The ideal candidate will be responsible for ensuring that all processes, documentation, and operations meet regulatory and quality requirements for medical device manufacturing and distribution.

Essential Functions of the Position:

• ISO 13485:2016 Compliance:
  • Maintain and continuously improve the QMS to ensure full compliance with ISO 13485:2016.
  • Lead internal and external audits, including regulatory inspections.
  • Ensure proper documentation control and record retention in accordance with ISO standards.
• Quality Assurance & Control:
  • Develop and implement quality policies, procedures, and objectives.
  • Monitor product quality and process performance using appropriate metrics.
  • Investigate non-conformances and implement corrective and preventive actions (CAPA).
• Training & Leadership:
  • Train staff on quality procedures, regulatory requirements, and ISO 13485:2016 standards.
  • Lead cross-functional teams in quality improvement initiatives.
  • Foster a culture of quality and continuous improvement throughout the organization.
• Supplier & Risk Management:
  • Evaluate and monitor supplier quality performance.
  • Conduct risk assessments and ensure risk-based thinking is applied across the QMS.
• Regulatory & Documentation:
  • Ensure compliance with applicable regulatory requirements (FDA, EU MDR, etc.).
  • Oversee document control systems and ensure timely updates and approvals.
  • Drive and support continuous improvement related to safety, quality, and cost

Position Qualifications:

• Bachelor of Science degree in the field of quality management, engineering, or business preferred.
• Practical experience in quality management with Lean Six Sigma Green Belt, Certified Quality Engineer (CQE), or Certified Manager of Quality/Organizational Excellence (CMQ/OE) will be considered in lieu of a bachelor’s degree.
• Entrepreneurial when it comes to utilizing and implementing AI and Automation of systems and processes
• 3-5 years of combined professional experience in the field of Quality control in manufacturing
• 2-3 years of supervisory role
• Knowledge of FDA/ISO Regulated Medical Device Procedures preferred
• Represent Wacker’s interests towards authorities, suppliers, and contractors
• Support work in interdisciplinary and intercultural teams
• Perform all tasks and assignments in accordance with Wacker’s policies and procedures
• Collaborate with internal/external expert committees / working groups
• This position requires working in a multi-disciplinary team with multiple interfaces to internal customers (R&D, operations, supply chain), internal services like EHSS, procurement, accounting, and controlling, as well as external parties like authorities, suppliers, and contractors.

• Compensation and Incentive plans
• Medical, Dental, and Vision Insurance effective day 1
• Paid Time Off in addition to personal days and holidays
• Paid parental leave
• Wellbeing fund
• Flexible hybrid work arrangements
• 401(k) with company match
• Education Assistance Program
• Career development and advancement opportunities
• Support for Community Involvement