Quality Inspector

Exsurco Medical•Wakeman Township, OH

14d•Onsite

About The Position

The Quality Inspector role involves a primary focus on incoming inspection, ensuring materials meet all required standards against drawings, specifications, regulatory, quality, and company requirements. This position also supports in-process and final inspections, calibration program maintenance, and quality system support. The role requires a hands-on approach in both office and manufacturing settings, with regular standing, walking, and the ability to lift up to 50 lbs.

Requirements

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.
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.
Diplomacy, persistence and persuasion abilities required.
Strong verbal, written, analytical and interpersonal skills.
Able to present information to management.
Regular standing, walking, and use of inspection equipment.
Ability to lift up to 50 lbs.

Nice To Haves

Experience in medical devices or ISO 13485 / FDA 21 CFR 820 environment

Responsibilities

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).
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.
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.
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.