Quality Control Inspector II - Mon -Th, 2nd Shift (10 hr shifts)

Integra LifeSciences Corporation; Plainsboro Township (NJ); On-site; USD 50,000 - 70,000; Full time

Job summary

A leading company in healthcare is seeking a Quality Control (QC) Inspector II to ensure products meet safety and regulatory standards. The role involves inspection, documentation, and collaboration with teams to resolve quality issues. Candidates should have a high school diploma and relevant QA experience, with strong communication and problem-solving skills.

Qualifications

• GMP/GLP experience in pharmaceutical or medical device inspections.
• QA experience in medical devices preferred.

Responsibilities

• Examine raw materials, in-process components, and finished products.
• Maintain detailed records of inspections and test results.
• Ensure compliance with FDA's GMP or ISO standards.

Skills

Communication

Organizational

Problem Solving

Education

High school diploma

Tools

Microsoft Office Suite

Job description

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

Position: Quality Control (QC) Inspector II

The QC Inspector II plays a critical role in ensuring that products meet safety, performance, and regulatory standards before reaching the market. Responsibilities include:

1. Inspection and Testing: Examine raw materials, in-process components, and finished products for defects or non-compliance through visual, mechanical, and functional tests, ensuring adherence to standards like FDA or ISO.
2. Documentation and Reporting: Maintain detailed records of inspections, test results, deviations, and support root cause analysis, collaborating with engineering or production teams.
3. Regulatory Compliance: Ensure processes and products comply with industry regulations such as FDA's GMP or ISO standards. Assist in audits and CAPA implementation.
4. Collaboration with Teams: Work closely with production, engineering, and design teams to resolve quality issues and contribute to process improvements.
5. Training and Support: Provide training on quality standards and assist in developing SOPs for inspection processes.

This role is scheduled Monday to Thursday, 2nd shift (10 hours per shift). To succeed, individuals must perform essential duties satisfactorily.

1. Perform inspections using various measurement and test equipment to accept or reject materials or parts.
2. Conduct first article, incoming, and in-process inspections, determining acceptance or rejection.
3. Interpret drawings, specifications, and procedures to assess materials.
4. Review sampling as per ANSI standards.
5. Assist in reviewing and disposition of non-conforming and returned materials.
6. Maintain accurate inspection and testing records.
7. Coordinate inspection status with other departments to support production and project goals.
8. Participate in continuous improvement initiatives.
9. Maintain quarantine areas and inspection areas in order.
10. Work in classified clean rooms as necessary.
11. Perform line clearances and quality reviews during manufacturing activities.
12. Identify opportunities for process and documentation improvements.
13. Provide quality support to various departments.
14. Assist in training new associates on quality systems and SOPs.
15. Perform other duties and projects as assigned.

Minimum Requirements:

• High school diploma required.
• GMP/GLP experience in pharmaceutical or medical device inspections.
• QA experience in medical devices preferred.
• Strong communication, organizational, and problem-solving skills.
• Knowledge of CAPA, Validations, Change Control preferred.
• Understanding of ISO 13485, 21CFR820, FDA QSR, and cGMP.
• Proficiency in Microsoft Office Suite.
• Ability to analyze problems, collect data, and work independently.

Integra LifeSciences is an equal opportunity employer committed to diversity and inclusion. For more information on your rights, see the EEO notices linked in the original description. For accommodations, contact [e-mail] or call 855-936-2666.