Quality Inspector

RESPONSIBILITIES:

The duties & responsibilities of the Quality Inspector include, but are not necessarily limited to the following:

Inspection

Incoming Inspection (Primary Focus)

• Inspect incoming materials against drawings, specifications, regulatory, quality and company requirements.
• Receive materials and perform necessary transactions within ERP.
• Perform accept/reject decisions and ensure timely disposition to avoid production delays.
• Identify and document nonconforming materials; initiate nonconformance records.
• Coordinate with Supply Chain and suppliers on rejected materials and returns.
• Ensure all incoming inspection documentation is complete, accurate, and scanned/filed appropriately.
• Support continuous improvement of incoming inspection processes (sampling, methods, efficiency).

In-Process & Final Inspection

• Perform in-process inspections to ensure products meet requirements throughout manufacturing.
• Support final inspection and release activities.
• Work directly with Operations to address quality issues in real time.
• Escalate issues that may impact product quality, delivery, or compliance.
• Support inspection method improvements to increase repeatability and reduce variability.

Calibration

• Responsible for overall maintenance and control of calibration program to include, but not limited to:
• Maintain the calibration program for all measuring and test equipment.
• Ensure all equipment is calibrated on time and remains fit for use.
• Track calibration status and coordinate with external vendors as needed.
• Evaluate calibration intervals and equipment suitability for product tolerances.
• Maintain calibration records in compliance with regulatory requirements.
• Provide a forecast of calibration costs for the Quality department budget.
• Perform and assist in calibration activities, as required.

Quality System Support

• Maintain compliance to the Exsurco Quality Management System.
• Support nonconformance investigations and closure activities.
• Support audits (internal, external, FDA, notified body) by providing inspection and calibration records.
• Assist with basic quality data tracking (inspection results, trends, defects).
• Participate in continuous improvement efforts across Quality and Operations.
• Maintain quality records per applicable SOPs.
• Assists QA/RA Manager with creation of ISO procedures, SOPs and Forms.
• Assists QA/RA Manager overseeing the Quality Assurance tasks and processes, as required.

Skills/Qualifications:

Education and Experience:

• Associate degree or equivalent experience required.
• 1–3 years of experience in quality inspection, manufacturing, or regulated industry preferred.
• Experience in medical devices or ISO 13485 / FDA 21 CFR 820 environment preferred.

Competencies/Key desired behaviors/Skills:

• Strong attention to detail and ability to make sound accept/reject decisions.
• Must display high level of accuracy and accountability.
• Ability to achieve results within assigned deadlines.
• Ability to prioritize multiple tasks and operate in a fast-paced environment.
• Comfortable reading drawings, specifications, and work instructions.
• Hands-on experience with measurement tools (calipers, micrometers, gauges, etc.).
• Ability to work independently and take ownership of assigned areas.
• Strong organizational skills in a fast-paced, low-structured environment.
• Basic proficiency in Excel and ERP systems.
• Practical problem-solving mindset.

Communication Skill Requirements:

• Diplomacy, persistence and persuasion abilities required.
• Strong verbal, written, analytical and interpersonal skills.
• Able to present information to management.

Other Requirements: e.g., working conditions, physical requirements, travel, etc.

• Hands-on role in both office and manufacturing settings.
• Regular standing, walking, and use of inspection equipment.
• Ability to lift up to 50 lbs.
• Other duties as assigned.

Pay: $20.00 - $30.00 per hour

Work Location: In person