Quality Engineer II

Job DescriptionJob Description

About the Role

We are seeking a driven and detail-oriented Quality Engineer II to join our team. This role plays a key part in ensuring our products and processes meet the highest standards of quality, safety, and compliance . You will be engaged in technical quality activities, continuous improvement projects, and cross-functional collaboration, helping to deliver goods and services that meet our customers' expectations for quality, quantity, and timeliness

If you are looking for an opportunity to grow your career, bring your expertise to the next level, and make a direct impact on product quality and patient safety, this position may be a great fit.

Key Responsibilities

• Enforce and support the Quality Management System and applicable SOPs.
• Perform, review, and approve testing and inspection activities, including training quality inspectors and technicians.
• Develop and implement solutions that streamline and improve quality processes
• Support calibration and preventative maintenance of gauges and equipment.
• Optimize inspection methods, sampling plans, and documentation processes.
• Review and approve manufacturing documentation and engineering changes to ensure compliance and proper justification.
• Support production inspections, evaluate nonconforming parts, and complete nonconformance reports.
• Partner with process owners to resolve nonconformances and drive corrective and preventive action (CAPA) activities.
• Author and execute validation protocols and reports, including process, software, and test method validations.
• Support and participate in internal, external, and supplier audits as well as follow-up actions.
• Review and approve sterilization cycle results and support cycle validations where applicable.
• Leverage ERP systems to drive quality improvements and efficiencies.
• Provide overall quality and production support to meet business objectives.
• Monitor and report on quality trends and performance indicators.

Qualifications & Skills

BS in Engineering or equivalent experience.

Minimum 3 years of experience in Quality Engineering for medical devices or 5+ years in quality roles overall.

Strong knowledge of disposable medical device testing, validation protocols, and report writing.

Excellent communication (written and verbal).

Why Join Us?

Apply Today

If you are passionate about quality, eager to bring new ideas, and ready to make an impact, we invite you to apply and join our team as a Quality Engineer II

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