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.

 PERSONAL CHARACTERISTICS:

 Behave Ethically:  Understand ethical behavior and business practices and ensure that own behavior and the behavior of others is consistent with these standards and aligns with the values of the organization.

Communicate Effectively:  Speak, listen and write in a clear, thorough and timely manner using appropriate and effective communication tools and techniques.

Creativity/Innovation:  Develop new and unique ways to improve function efficiency and performance.

Foster Teamwork:  Work cooperatively and effectively with others to set goals, resolve problems, and make decisions that enhance process effectiveness.

Organize:  Set priorities, develop a work schedule, monitor progress towards goals, and track details/data/information/activities.

Plan:  Set goals, create and implement actions plans, and evaluate the process and results.

Solve Problems:  Assess problem situations to identify causes, gather and process relevant information, generate possible solutions, and make recommendations to manager.

Exsurco Values: Aligns to and demonstrates Empowerment, Unity and Commitment.