Quality Engineer - Frederick, United States - Medix

Medix Frederick, United States

2 weeks ago

Description

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.

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