Design Project Quality Engineer

Company Description

medmix es líder mundial en dispositivos de administración de alta precisión, con posiciones de liderazgo en los mercados finales de la sanidad, consumo y la industria.

Nuestros clientes se benefician de nuestra orientación a la innovación y al avance tecnológico, que se ha traducido en más de 900 patentes activas.

medmix tiene su sede central en Baar, Suiza y 14 centros de producción en todo el mundo, que, junto con nuestro equipo altamente motivado y experimentado de casi 2.700 empleados, estamos al servicio de nuestros clientes con una calidad, proximidad y agilidad sin concesiones. Nuestras acciones cotizan en el SIX Swiss Exchange (SIX: MEDX). www.medmix.swiss

Job Description

Job purpose

The Design Project QE facilitates site regulatory compliance for medmix Healthcare US Inc for incoming project design transfers. This individual ensures product reliability and regulatory compliance throughout the design and development lifecycle, bridging the gap between engineering design, manufacturing, and quality standards. They manage the design transfer to the manufacturing site, risk assessment (ISO 14971), and verification/validation (V&V), crucial in regulated industries like medical devices, pharmaceutical, or manufacturing and will assist with the development of processes and procedures that the DEA and FDA require for cGMP compliance when processing combination drug product. This individual will help to ensure that all required DEA records are retained in a manner that they are easily retrievable and are complete in order to show inventory control and accountability. They will also assist with completing year-end inventories, inventory reconciliation, discrepancy investigations, and support or represent the business in matters of FDA and DEA investigations and audits. This role is critical in maintaining adherence to regulations, processing Standard Operating Procedures (SOPs), and regulatory compliance for controlled substances. The individual must demonstrate strong leadership and organizational skills, collaborating with Operations, Quality Assurance, Security, and other departments to ensure compliance and prevent risks related to controlled substances. The individual also supports continuous improvement initiatives related to design transfer, validation, and compliance readiness, helping to strengthen inspection outcomes and reduce regulatory risk.

Main accountabilities and tasks

1. Assist with the implementation and maintenance of the controlled substance program to include:
   • Procedure development and creation
   • Process development and implementation
2. Will interpret design transfer documents into functional manufacturing outputs to ensure compliance with GMP guidelines.  
3. This individual may support training and guidance for site personnel on design transfer, controlled substance handling, and regulatory expectations to promote consistent compliance across the organization
4. Monitor changes in regulations and update internal processes and policies as needed to maintain compliance.
5. Assist with site gap assessments and development of action plans to ensure DEA, FDA, and state law cGMP compliance.
6. Track, trend, and report CS related compliance metrics and risks to site leadership
7. Responsible for working through all CS inventory discrepancies to final resolutions.
8. Responsible for completing all CS inventory accountability and reconciliation activities.
9. Support all DEA inspections, correspondence, and help ensure site readiness.
10. Assist with completing and submitting all appropriate CS documents to the FDA and DEA on time and within guidelines which include but are not limited to:
    • Registrations
    • DEA 106 Reports
    • DEA 41 Forms
    • Permits
11. Maintains all records and documentation for CS.
12. Provide training and education to staff on, documentation of controlled substances.
13. Assists with developing and growing a security culture among all colleagues and contractors to ensure CS compliance.
14. Collaborates cross-functionally to gain alignment on compliance and quality issues.
15. Develop procedures and handle reporting of all CS destruction activities.
16. Responsible for handling all CS customer complaints including all samples returned to medmix Healthcare US Inc.
17. Represent the business on all DEA matters and attend client and regulatory audits and inspections, ensuring the site is audit ready.

Qualifications

Desired experience and qualifications

Work experience:

• Minimum 3 years of related working experience in a pharmaceutical or regulated industry is required.
• Experience working with standard ERP/M