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.