What are the responsibilities and job description for the Quality Engineer position at Kindeva Drug Delivery?
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.
Assists and supports the manufacturing/packaging staff in detecting and solving compliance errors in real time during manufacturing and packaging operations.
Participates in understanding failures and resulting CAPAs through notice of event reports
Works closely with manufacturing, Technical Services, QA, P&I, and other departments as needed to support project initiatives.
Able to determine product acceptability and compliance with cGMP’s identify issues that may impact the product and compliance with regulations.
Works 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.
Collects and reports data
Participates in internal GMP audits and supports customer and regulatory audits
Collects, researches and analyzes data
Assists in review and editing of SOPs / Master Batch Records
BASIC QUALIFICATIONS
Bachelor’s degree in a scientific or engineering discipline, or equivalent experience in lieu of a degree.
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.
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