About this role
Job title: Quality Control Technician II
About the Role The Quality Control Technician II performs acceptance testing and inspection activities on in-process and finished goods to ensure products meet established requirements in a regulated manufacturing environment. This role works in a clean room with full gowning/PPE to support patient safety and quality compliance.
What You'll Do
- Perform functional acceptance testing and inspections on products assembled on the manufacturing floor in accordance with approved procedures and test methods.
- Conduct independent review of Shop Floor Paperwork (SFP) to verify completeness and accuracy before product release or further processing.
- Identify and subject non-conforming materials to the NCMR process per quality procedures.
- Accurately document test results, inspections, and related quality records.
- Read, comprehend, and follow job instructions, procedures, protocols, and related documents; communicate as needed.
- Train Inspectors on acceptance testing methods, procedures, and new policies.
- Assess daily priorities and adjust your schedule to support operations.
- Participate in team meetings and quality discussions.
- Serve as final quality control checkpoint for finished products; responsible for release decisions to ensure patient safety.
- Collect, record, and maintain data for Statistical Process Control (SPC); perform routine data trending; escalate trends or risks to Quality Management.
- Develop understanding of full production workflow to improve judgment during final release.
- Support proactive quality by identifying opportunities to prevent defects.
- Perform additional duties as assigned.
What We're Looking For
- High school diploma or equivalent required; associate or bachelor’s degree in science, Math, Business, or related field preferred.
- Minimum of 2 years’ experience in a quality function or regulated environment, or bachelor’s degree or Certified Quality Technician (CQT) certification.
- FDA-regulated environment experience preferred; medical device experience strongly preferred.
- Ability to perform functional testing, inspections, and basic measurements accurately.
- Prior Instron testing experience or training in Series IX, Merlin, or Blue Hill preferred.
- Competence in reviewing documentation for completeness and compliance.
- Strong math skills across units of measure; data integrity focus.
- Experience using electronic quality systems and databases for data entry and record maintenance.
- Excellent written and verbal communication; ability to work collaboratively; flexible and quick to learn.
- Ability to work independently, manage multiple priorities, and adapt to changing workflows.
- Proficiency with Microsoft Office.
Nice to Have
- Experience working in an ISO Class 7 cleanroom environment.
Compensation & Benefits
- Salary range: $27/hr - $29/hr plus overtime.