Quality Engineer - Apple & Associates, Inc

Apple and Associates is currently looking for Quality Engineers to join an engineering team in the medical device industry, focusing on calibration, validation, equipment qualification, process improvement, and vendor coordination. This role is essential for providing support to technicians and staff, enhancing infrastructure, and ensuring effective and timely engineering practices. The ideal candidate will contribute to improving efficiency across various areas using their experience in calibration, and validation management.

About the Role:

Job Tasks and Responsibilities

• Equipment Calibration: Manage the tracking and scheduling of equipment calibration. Oversee the calibration management program and coordinate with vendors to ensure timely execution.
• Validation Management: Plan, track, and schedule validation activities. Approve and oversee validation protocols, and coordinate scheduling with third-party vendors.
• Change Control: Develop and implement change controls for managing change requests.
• Project Coordination: Collaborate with the engineering and quality departments to ensure project deadlines are met and maintain readiness.
• Continuous Monitoring: Continuously monitor, track, report, and maintain systems to ensure optimal performance.

Qualifications:

Bachelor of Science in Mechanical Engineering or equivalent. 2+ years with mechanical experience or related projects. Excellent computer and critical thinking skills. Sterile Manufacturing in a pharmaceutical setting.

Required Skills:

• Strong analytical skills
• Manage Equipment Calibration
• Strong Validation Management Skills

Preferred Skills:

• Experience in FDA regulations
• Project management experience
• Knowledge of Six Sigma principles

Equal Opportunity Statement:

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.