Imagine a career with purpose and possibility at TekniPlex, where you'll join a global team of problem-solvers in materials science to make life better. You'll be part of a company that improves patient outcomes in healthcare and protects essential consumer goods. Our work touches daily life, and we're united by one purpose: creating safer, smarter solutions.
Requirements
- Maintain and improve the site's Quality Management System in alignment with ISO 13485 requirements
- Administer document control processes, including creation, revision, approval, and archival of controlled documents
- Support internal and external audits, including preparation, execution, and follow-up on audit findings
- Lead and/or support Corrective and Preventive Actions (CAPA), ensuring timely and effective resolution
- Manage nonconformance processes, including investigation, documentation, and disposition
- Assist with training program administration to ensure employees are trained and compliant with QMS requirements
- Support risk management activities and ensure proper documentation in accordance with applicable standards
- Monitor quality system metrics and generate reports to support management review
- Collaborate cross-functionally with manufacturing, engineering, and other departments to drive quality improvements
- Ensure compliance with data integrity principles (e.g., ALCOA++) and good documentation practices
- Participate in change control processes, assessing impact and ensuring proper implementation
Benefits
- Medical Coverage
- Prescription Drug Coverage
- Telemedicine
- Dental Coverage
- Vision Coverage
- Employee Assistance Program
- Health Savings Account (HSA)
- Flexible Spending Account (FSA)
- Basic Term Life/AD&D Insurance
- Voluntary Life/AD&D Insurance
- Short Term Disability (STD)
- Long Term Disability (LTD)
- Voluntary Buy-Up LTD
- Hospital Indemnity
- Accident Insurance
- Critical Illness
- 401(k) Retirement Savings Plan
- Daily Pay
- Business Travel Insurance
- Legal Plan
- Identity Protection
