Quality Engineer III

Job Description: Quality Engineer

We are seeking an experienced Quality Engineer to join our team in a production environment, preferably with expertise in flexible packaging. The successful candidate will have a minimum of 5+ years of experience as a Quality Engineer at the same company.

Responsibilities:
- Conducting customer complaint investigations, including root cause analysis, on the production floor and engaging in customer contact and interaction. This will be the primary focus for the first 6 months to a year.
- Managing a Quality lab team (previous experience preferred).
- Ensuring compliance with ISO 13485 standards, with a minimum of 3 years of experience working in an ISO 13485 environment.
- Utilizing previous ERP/MRP experience.
- Demonstrating proficiency in MS Office applications (Excel, Word, PowerPoint, and Outlook).
- Collaborating effectively with other departments to communicate timelines, priorities, and resolve ambiguous tasks/situations.
- Exhibiting strong organizational skills and the ability to share knowledge and effectively communicate with others.

Requirements:
- Bachelor's degree in Engineering or a related field.
- 3+ years of experience as a Quality Engineer at the same company.
- Experience owning the CAPA (Corrective and Preventive Actions) process, including root cause analysis on the production floor.
- Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) certification preferred.
- Familiarity with customer or regulatory audits is preferred.
- Ability to work in a packaging environment with gray areas, where regulatory requirements may not be as clearly defined as in FDA or pharmaceutical settings.
- Strong leadership skills and the desire to grow within a small team environment.
- Confidence in managing employees and handling difficult conversations and situations with internal and external customers tactfully.



We look forward to welcoming a dedicated and experienced Quality Engineer to our team