Quality Laboratory Supervisor

Quality Laboratory Supervisor

Do you want to take responsibility and make a difference with your work? With your expertise, we can achieve great goals together. We are WACKER - Reliable. Determined. Ambitious. As one of the world's most research-intensive chemical companies, we've been making countless products that are an integral part of your everyday life possible for over 100 years. From vegan food to resource-efficient buildings to solar cells, we develop sustainable solutions that change the future. To strengthen our team in Allentown, we are looking for you as a Quality Laboratory Supervisor. 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.

What Do We Offer?

WACKER strives to reward its employees in a fair and equitable manner. Our Total Rewards Package considers employee wellbeing and is comprised of compensation, benefits, work-life balance, performance & recognition, and career development.

We are looking forward to your online application at www.wacker.com. Reference Code : 30331