Quality Laboratory Supervisor at Wacker Chemical Corporation

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(n) Quality Laboratory Supervisor. The Quality Supervisorwill lead and maintain our Quality Management System (QMS) in compliance withISO 13485:2016standards. 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 costPosition Qualifications: Associates Degree required, Bachelor's Degree preferredPractical experience in quality management with Lean Six Sigma Green Belt, Certified Quality Engineer (CQE), or Certified Manager of Quality/Organizational Excellence (CMQ/OE) preferredEntrepreneurial when it comes to utilizing and implementing AI and Automation of systems and processes5+ years of combined professional experience in the field of Quality control in manufacturing2-3 years of supervisory roleKnowledge of FDA/ISO Regulated Medical Device Procedures preferredRepresent Wacker's interests towards authorities, suppliers, and contractorsSupport work in interdisciplinary and intercultural teamsPerform all tasks and assignments in accordance with Wacker's policies and proceduresCollaborate with internal/external expert committees / working groupsThis 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. 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.Compensation and Incentive plansMedical, Dental, and Vision Insurance effective day 1Paid Time Off in addition to personal days and holidaysPaid parental leaveWellbeing fundFlexible hybrid work arrangements401(k) with company matchEducation Assistance ProgramCareer development and advancement opportunitiesSupport for Community InvolvementWe are looking forward to your online application at www.wacker.com.Reference Code:30331The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. A minimum requirement for this US-based position is the ability to work legally in the United States on a permanent unrestricted basis. Visa sponsorship is not available for this position, including any type of US permanent residency (e.g., for a green card).Wacker is an Equal Opportunity Employer. We actively promote the equality of opportunity for all who are qualified and bring the requisite experience, talent, skill and potential, without regard to age, disability, sex, race, religion or belief, marriage/civil partnership, pregnancy/maternity, sexual orientation, or any other protected characteristics. We welcome all applications from a wide range of candidates. Selection for roles will be based on individual merit alone.