Quality Engineer

Our manufacturing site in Flowery Branch Georgia is actively searching a Quality Engineer. This position will be responsible for assisting with the implementation, management, and administration of the quality management system and ensuring products are manufactured per quality and regulatory requirements and industry best practices.

Main accountabilities and tasks

1. Assist in monitoring the Quality System, including review of records and process results, to ensure product quality and regulatory compliance.
2. Support continuous improvement efforts within the Quality System.
3. Maintain knowledge of current regulatory requirements for medical device manufacturing and combination product manufacturing and communicate key requirements to staff.
4. Ensure manufacturing and quality documentation is accurate, controlled, and compliant with GMP, internal procedures, and regulatory standards.
5. Conduct weekly quality walk‑throughs to assess compliance and identify improvement opportunities.
6. Ensure compliance with OSHA and other applicable health and safety regulations.
7. Conduct internal audits in accordance with current ISO standards and FDA regulations.
8. Administer and maintain the ISO Quality System, including certification renewals, quality manuals, quality records, process maps, and work instructions.
9. Understand and apply relevant FDA regulations (e.g., 21 CFR Part 4).
10. Maintain and apply knowledge of company policies, regulations, and industrial processes
11. Maintain quality records procedures and support the nonconformance reporting process.
12. Review and approve nonconformance reports; coordinate cross‑department follow‑up; calculate cost of quality; and identify trends or significant issues for management escalation.
13. Lead investigations of quality issues as required, using structured root‑cause analysis techniques.
14. Provide analysis and trending data to support issue investigations and CAPA activities.
15. Collaborate cross‑functionally to address containment actions and implement corrective actions.
16. Conduct risk assessments using tools such as PFMEA.
17. Assist in setting standards for thorough and timely QA documentation review.
18. Provide constructive feedback to QA and Operations personnel regarding documentation quality.
19. Write and revise quality manuals, procedures, policies, and related work instructions.
20. Participate in continuous improvement initiatives to maintain regulatory compliance and improve operational quality.
21. Recommend enhancements to improve quality performance and operational efficiency.
22. Perform other duties and additional projects as assigned by management.