Quality Engineer

Posted Tuesday, March 18, 2025 at 4:00 AM Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make In this role, you will develop, direct, and lead Quality oversight for process improvements in equipment and material preparation, aseptic compounding, filling, inspection, and packaging at the Brentwood, Maryland Heights, and Bridgeton facilities. You will coordinate support activities, reviews, audits, and the release of semi-finished products and components to align with site-wide objectives. You will collaborate with cross-functional teams to support continuous improvement initiatives, incident investigations, and change management. Additionally, you will make decisions related to Incident Investigations and Corrective and Preventive Actions, ensuring a focus on overall quality, site priorities, and operational success. ROLE RESPONSIBILITIES Understand the manufacturing operations and quality procedures for the area(s) to facilitate compliance to regulations. Assist and support the manufacturing/packaging staff in detecting and solving compliance errors in real time during manufacturing and packaging operations. Participate in understanding failures and resulting CAPAs through notice of event reports. Work closely with manufacturing, Technical Services, QA, P&I, and other departments as needed to support project initiatives. Determine product acceptability and compliance with cGMP’s, identifying issues that may impact the product and compliance with regulations. Work independently, with minimal guidance and under short timelines while maintaining quality work. Able to work in a team environment within own team and interdepartmental teams. Collect and report data. Participate in internal GMP audits and support customer and regulatory audits. Collect, research, and analyze data. Assist in review and editing of SOPs / Master Batch Records. BASIC QUALIFICATIONS Bachelor’s degree in a scientific/engineering discipline. Minimum of three (3) years of cGMP, FDA regulated industry experience; prefer experience within the medical device or Quality Engineering settings. 1-3 years of experience with a Master’s degree acceptable. Knowledge of computerized systems (MS Office suite). Demonstrated ability to manage multiple priorities. Professional certification is desirable but not required (i.e. CQA – Certified Quality Auditor, CQE – Certified Quality Engineer, SQE – Software Quality Engineer, etc.). Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. Do you see yourself as part of the Kindeva mission? Click Apply Now Today! #J-18808-Ljbffr Kindeva Drug Delivery