We seek an experienced QC Tech 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 bachelors 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.