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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.

The Quality Engineer I will play a key role in supporting the identification, investigation, and closure of Non-Conformities and in managing the Training Management process. Additional responsibilities include participation in supplier management, validation activities, and environmental monitoring programs.

Supervision Received

The Quality Engineer I receives direct supervision from the Quality Assurance Manager.

Supervision Exercised

The Quality Engineer I is an individual contributor and has no supervisory responsibilities.

Key Responsibilities

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:

• Non-Conformities Management:

• Assist in identifying, investigating, and resolving Non-Conformities (NCs) to ensure timely and effective closure.

• Conduct root cause analysis and implement corrective actions to address identified issues.

• Maintain detailed records and documentation associated with the NC process.

• Training Management:

• Support the development, implementation, and maintenance of the Training Management system.

• Ensure training programs are up-to-date, compliant, and aligned with Quality System requirements.

• Monitor training completion and maintain training records for compliance purposes.

• Supplier Management Activities:

• Assist with supplier approvals, audits, and corrective actions as part of the Supplier Management program.

• Validation and Qualification Activities:

• Participate in validation efforts such as equipment qualifications, cleaning validations, sterilization validations, and process validations.

• Environmental Monitoring:

• Support monitoring and reporting activities related to cleanroom environments, vector control, and product bioburden testing.

• Additional Quality Support:

• Investigate and trend customer complaints and product non-conformances.

• Develop and maintain inspection programs for incoming, in-process, and final products.

• Provide technical assistance to cross-functional teams including Marketing, Operations, and Regulatory.

• Contribute to quality improvement initiatives and lean projects.

• Other Duties:

• Perform other duties as assigned by management.

Desired Minimum Qualifications

Education:

• Bachelor's degree in engineering or a related discipline required.

Experience:

• Knowledge of FDA QSR and ISO Quality Standards.

• Some experience in a quality or compliance role in the medical device or similarly regulated industry.

• Experience with Root cause analysis, technical writing, and process improvement is preferred.

• Experience with Training Management systems and Non-Conformance processes is preferred.

Skills:

• Excellent communication and organizational skills.

• Proficient in Microsoft Office Suite (Word, Excel, Outlook).

• Strong attention to detail and ability to manage multiple tasks simultaneously.

Tools and Equipment Used

• Standard office equipment: computers, telephone, and copy machines.

• Quality tools: vernier calipers, micrometers, thread/plug gauges, and optical comparators.

Physical Requirements

• Ability to travel up to 10%.

• Frequent use of hands, eyes, and coordination to operate office and testing equipment.

• Ability to lift and move objects up to 20 pounds occasionally.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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