Quality Engineer

Quality Engineer

Requirements

• Bachelor’s degree in Engineering or equivalent or a related field.
• 2-3 years (+) experience in Quality Assurance/Quality Engineering from medical device or pharmaceutical industry.
• Sufficient knowledge in test method validations & statistical analyses.
• Regulations experience in any: 21 CFR 820, FDA, 13485, 14971.
• Proven experience in relevant areas of Quality, Regulatory or Engineering, preferably within a medical device environment.
• Advanced knowledge of relevant regulations is required to act as a resource for colleagues.
• Must be able to take accountability with excellent follow up and follow through.
• Strong written and verbal communication skills and ability to collaborate effectively.
• Capable of producing results working unsupervised under own initiative.
• Must be an effective team player with the ability to mentor, lead and problem solve to provide solutions to the business.
• Confident and open personality who is able to communicate effectively, both written and orally with people at all levels.

Responsibilities

• Plans for, executes and documents test method validations for receiving inspection methods and in-house manufacturing inspection methods.
• Supports receiving inspection and/or in-house manufacturing as applicable and necessary.
• Supports equipment/tooling asset managements, such as the handling of new creations, deactivations, calibration or preventative maintenance issues, and/or documentation of loss assessments.
• Supports or owns executions of non-conformance reports, which may include the preparation of associated metrics.
• Liaises with other Abbott sites to ensure compliance to quality system.
• Works within a GMP environment and documents results per GDP standards. Holds R&D, and operations accountable to GMP and GDP requirements.
• Supports sterilization activities and documentation (submission forms, LAL, Bioburden, etc.)
• Leads cross-functional teams to achieve consensus for deliverables associated with quality issues.
• Maintains inspection procedures for the inspection of incoming materials, in-process materials and finished goods. Select appropriate inspection, test and measurement equipment, fixtures, and gauges.
• Ensures compliance with all procedures and all applicable regulatory agency requirements.
• Identifies continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for improvement and optimization.
• Works with engineers and manufacturing to transfer technical information into easy to understand written form, as well as take a hands-on approach to learning and documenting the processes.
• Other duties as assigned.

Preferred Qualifications

• Experience with equipment/tooling management logistics a plus.
• Experience with external/internal audits and EtO Sterilization a plus.