Quality Engineer

This role will provide Validation, Risk Management (Quality Function Deployment), and Investigation (Non-conformances and CAPA) leadership for the Lexington Mill in support of the technical quality organization of manufacturing business. the Quality Engineer coordinates; and maintains activities required for risk management; process, product, software, and equipment validations; and investigates and documents non-conformances and Corrective/Preventative Actions. The Quality Engineer ensures conformance to requirements for the activities related to production and process control, process validation, risk management, inspection, acceptance, and non-conforming product. Additional duties include participation in the change management process and interfacing with production and other personnel to perform the required validations and risk assessments. Build strong working relationships with key stakeholders within our organization.

Core Responsibilities

• Ensure GMP and Quality System compliance for Validation.
• Initiate, create, review, and approve validation and re-validation protocols.
• Train others on validation protocols as needed. Develop process validation/verification skills within the Mill Team.
• Ensure sound statistical techniques and sampling plans are applied to process validation.
• Collect, document, and analyze data and other information required by the validation protocols and prepare final reports for completed validations.
• Ensure GMP and Quality System compliance for Risk Management.
• Establish Product and Process FMEAs, Risk Management files, and control plans as required.
• Ensure sound statistical techniques and sampling plans are applied to incoming, receiving, in-process, and final inspection activities.
• Ensure acceptance activities and requirements are defined as needed and suitability of test/ inspection methods.
• Ensure adequate process controls are in-place and followed. Assist with process control optimization.
• Assist with investigation and root cause analysis of nonconformances and complaints.

Qualifying Experience

• A four year degree in Quality Engineering, Engineering, Chemistry, Biological Sciences, or a related field.
• 5 years of Quality and/or Process Engineering experience in a manufacturing environment is strongly preferred
• Knowledge of ISO - 13485 and ISO - 14971 is a strongly preferred.
• Working Knowledge of FDA regulations & GMP strong preferred.

If you feel this opportunity could be the next step in your career, we encourage you to apply.

Owens & Minor is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, sex, sexual orientation, genetic information, religion, disability, age, status as a veteran, or any other status prohibited by applicable national, federal, state or local law.

Note: Owens & Minor is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at our Company via email, the Internet, or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of our Company. No fee will be paid in the event the candidate is hired by our Company as a result of the referral or through other means.