We seek an experienced QC Engineer to support our medical device development, supply chain, inspection, and manufacturing activities. This individual will work with complex electromechanical medical devices that include single-use disposables. The right candidate will have sufficient technical aptitude to follow engineering and manufacturing specifications and technical drawings to carry out his/her responsibilities.

Key Responsibilities

• Responsible for inspecting all material intended for production use and documenting inspection results.
• Responsible for in-process and finished device inspection.
• ·Responsible for proper segregation and quarantine of suspect material and maintaining records associated with these activities.
• Assist with equipment IQ, OQ, PQ and testing, and properly documenting these activities.
• Assist with executing Verification & Validation tests and documenting test results.
• Assist with administering the equipment calibration and equipment PM process and associated records.
• Maintain accurate and timely records and documentation for all assigned activities as required.
• Maintain work area and equipment in a clean and orderly condition and follow prescribed safety regulations.

Required Qualifications

• High school diploma
• Medical device industry experience
• Cleanroom manufacturing experience
• 3-5 years of experience working in manufacturing, or QC, or engineering environments within a regulated industry (medical device, pharma, biotech, defense, space).
• Ability to manage multiple priorities is a must.
• Must be a self-starter and a fast learner.
• Must work efficiently, both independently and within a team environment.
• Must have good problem-solving skills and great attention to detail.
• Excellent written and verbal communication skills required.
• Basic computer skills are necessary.

Preferred Qualifications

• Associate or bachelor’s degree in science or engineering or relevant field.
• Experience working with inspection and test equipment including Digital Multimeters and Oscilloscopesips: Provide a summary of the role, what success in the position looks like, and how this role fits into the organization overall.