Quality Inspector

About the role

The Quality Inspector is responsible for coordinating, performing, and documenting quality inspections. This role helps ensure that all products are materially free of defects, that quality system procedures are followed, and that products are manufactured in a way that complies with company quality system and industry regulations.

Responsibilities

• Read and interpret engineering drawings, technical specifications, and standard operating procedures (SOPs).
• Select inspection samples based on recognized sampling methods and perform inspections of products using established procedures and specifications.
• Utilize tools such as calipers, micrometers, height gauges, pin gauges, and other metrology instruments to measure and verify components.
• Analyze inspection data.
• Accurately record inspection results and maintain quality reports and documents in multiple computer applications.
• Identify, document, and coordinate nonconformance control activities including identification, recording, disposition, supplier communication, sorting, rework, and resolution.
• Support root cause investigations and corrective and preventative actions (CAPA) as needed.
• Support and perform assigned project-based work.
• Effectively manage and track multiple tasks to completion.
• Collaborate effectively with engineering, production, and other teams to resolve quality issues.
• Participate in internal/external audits and continuous improvement projects as needed.
• Ensure adherence to ISO 13485, FDA 21 CFR Part 820, and other applicable regulations.
• Maintain a safe, neat and orderly work environment.
• Ensure and follow safety requirements and standards.
• Adhere to Company’s Quality System requirements.
• Perform all duties in a manner that follows, demonstrates, and promotes Company’s values.
• Report to work as scheduled, on time, and able to work entire work schedule.
• Perform additional duties as assigned.

Knowledge, Skills, and Ability

• Intermediate shop math, measurement systems, numeric conversion, and geometry competencies.
• Working knowledge of GD&T.
• Detail-oriented with the ability to analyze data and draw conclusions.
• Possess effective written and oral communication skills.
• Basic level skills using computer applications (Word, Excel, enterprise software).
• Ability to work effectively both independently and within a team environment.
• Ability to be highly adaptable and responsive to changing business needs.
• Possess a continuous improvement mindset.
• Critical thinking skills with the ability to analyze data and draw accurate conclusions.
• Ability to observe and identify details.
• Ability to work extended hours as scheduled, including weekends.

Physical Demands

• Frequent sitting, wrist manipulation, walking, and standing.
• Frequent sedentary work with lifting up to 10 pounds.
• Occasional medium work with lifting up to 50 pounds.
• Manual dexterity to type and operate office equipment occasionally.
• Must be able to complete all physical requirements to perform essential functions.

Qualifications

• Education: Quality Certifications such as ASQ-CQIA, CQI, or CQT preferred and/or ability to obtain.
• Experience Required:
  • Previous quality inspection experience including but not limited to: Gauge selection, use and care; Measurement techniques; Inspection records.
  • Experience reading and interpreting engineering drawings.
  • Manufacturing, mechanical, mechanical inspection, or machining experience.
  • Basic level experience with Microsoft Office programs (Word, Excel) and other enterprise software.
• Preferred: 2–3 years of quality inspection experience using calibrated measuring tools.
• Preferred: Experience working in a Quality Management System controlled environment (ISO 13485, ISO 9001, TS 16949) and/or an FDA regulated environment, preferably in medical device.

Working Environment

Standard working conditions include a temperature-controlled office and manufacturing environment.