Design Project Quality Engineer

Design Project Quality Engineer

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

• Interpret design transfer documents into functional manufacturing outputs to ensure compliance with GMP guidelines.
• Support training and guidance for site personnel on design transfer, controlled substance handling, and regulatory expectations to promote consistent compliance across the organization
• Monitor changes in regulations and update internal processes and policies as needed to maintain compliance.
• Assist with site gap assessments and development of action plans to ensure DEA, FDA, and state law cGMP compliance.
• Track, trend, and report CS related compliance metrics and risks to site leadership
• Responsible for working through all CS inventory discrepancies to final resolutions.
• Responsible for completing all CS inventory accountability and reconciliation activities.
• Support all DEA inspections, correspondence, and help ensure site readiness.
• 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

• Maintains all records and documentation for CS.
• Provide training and education to staff on, documentation of controlled substances.
• Assists with developing and growing a security culture among all colleagues and contractors to ensure CS compliance.
• Collaborates cross-functionally to gain alignment on compliance and quality issues.
• Develop procedures and handle reporting of all CS destruction activities.
• Responsible for handling all CS customer complaints including all samples returned to medmix Healthcare US Inc.
• Represent the business on all DEA matters and attend client and regulatory audits and inspections, ensuring the site is audit ready.

Desired experience and qualifications:

• Minimum 3 years of related working experience in a pharmaceutical or regulated industry is required.
• Experience working with standard ERP/MRP systems.
• Ability to manage multiple priorities effectively, balancing quality, compliance, and business needs while meeting timelines in a dynamic, regulated setting
• Experience interpreting compliance requirements and regulations is required.
• Knowledge of DEA, FDA, and state regulations pertaining to the manufacturing and shipping of controlled substances is preferred.
• General knowledge of DEA requirements as they relate to distribution and product supply is preferred.

Expertise (e.g. professional, technical):

• Proficient in Microsoft Office Suite (Excel, Word, PowerPoint) and experience with CRM software (Salesforce) and SAP.
• Customer centric approach, excellent verbal and written communication skills, with a strong ability to interact with customers and internal teams in various countries /time zones
• Demonstrate skills to solve complex problems in a wide variety of high pressure situations which require a high degree of ingenuity, creativity, and innovativeness.
• In situations where precedent may not exist, be able to independently exercise judgement, determine appropriate solutions, and take action.
• Demonstrate a strong ability to be adaptable and flexible.
• Demonstrate exceptional attention to detail and problem solving skills
• Demonstrate proven knowledge of business and management principles.
• Previous experience working with clients, auditors, inspectors, and regulatory agencies.
• Previous experience operating under FDA cGMP with a robust understanding of the principles and application associated with manufacturing operations.

Education: Level: Min. Bachelor's, Subject: scientific, engineering, or business

Languages: English

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