We are seeking a talented Senior Quality Engineer with biologics experience ensure that the highest standards of quality and compliance are met for our organization. This position will play a pivotal role in establishing and maintaining robust quality systems and processes to support our first-ever clinical trials through to our manufacturing processes. Working closely with cross-functional teams, this person will be responsible for implementing quality standards, conducting risk assessments, and driving continuous improvement initiatives to ensure compliance with regulatory requirements and industry best practices.

RESPONSIBILITIES:

• Establish quality systems/policies related to OOS, Deviations, CAPAs, NCMRs, and Complaints and work with various departments to ensure timely closure of related investigations.
• Document deficiencies, including root cause, corrective and preventive action plans.
• Ensure action plans are implemented in a timely manner.
• Support from a quality perspective, analytical test method qualification plans/protocols and reports.
• Assist with risk analysis activities and maintaining up to date risk management documents.
• Establish Quality Inspection Plans for the release of components, assemblies, and finished devices.
• Conduct quality inspections as needed.
• Support Manufacturing and R&D/Product Development, Analytical Development and Quality Control with statistical techniques, including design of experiments (DOE); sampling plans and data/ results analysis.
• Perform supplier evaluations as needed to assure supplier capabilities including the assessment of the adequacy of inspection methods, manufacturing practices, and control and quality procedures to deliver conforming products in a timely manner.
• Lead supplier audits and works with suppliers to resolve audit findings and/or nonconformances.
• Perform internal audits as needed.
• Responsible for quality engineering review of Document Change Orders.
• Set requirements for raw material or intermediate products for suppliers and monitor their compliance.
• Ensure adherence to regulatory requirements, and health and safety guidelines.
• Supervise inspectors, technicians and other staff and provide guidance and feedback.
• Quality oversite on all product development procedures to identify deviations from quality standards.
• Quality oversite on all product manufacturing processes and systems
• Quality oversite on all manufacturing output and ability to compare properties to requirements.
• Quality oversite on the sterilization and product release processes.

QUALIFICATIONS:

• Minimum of a BS in Biomedical Engineering, Chemical Engineering, Biochemistry, Chemistry or equivalent degree.
• 5 years relevant experience in Biologics/ Pharmaceutics. Experience in medical devices or combination products is a plus.