Quality Engineer - Medical Device Industry

Overview: We are seeking a proactive and detail-oriented Quality Engineer to support a high-impact initiative aimed at resolving a significant backlog of Nonconformances (NCs), Corrective and Preventive Actions (CAPAs), and customer Complaints. This role is critical to restoring compliance momentum and driving quality improvements across the organization.

Key Responsibilities:

• Lead investigations and drive NCs to closure with thorough documentation and timely execution.

• Manage CAPA projects from initiation through resolution, ensuring root cause analysis is robust and corrective actions are effective.

• Collaborate cross-functionally with Product Development, Engineering, and other stakeholders to implement and verify quality improvements.

• Prioritize and balance workload across NCs, CAPAs, and Complaints based on risk and regulatory impact.

• Maintain compliance with internal procedures and external regulatory requirements (e.g., FDA, ISO 13485).

• Contribute to continuous improvement initiatives and support audit readiness.

Qualifications:

• Proven experience managing NCs, CAPAs, and Complaints in a regulated industry.

• Strong background in root cause analysis and project management.

• Experience in medical devices strongly preferred; candidates from pharmaceutical or aerospace industries will also be considered.

• Bachelor's degree in Mechanical Engineering or related technical field is a plus.

• Excellent communication, documentation, and organizational skills.

Preferred Skills:

• Familiarity with ISO 13485, FDA QSR, and other relevant quality standards.

• Ability to work independently and manage multiple priorities in a fast-paced environment.

• Experience with quality systems, audit support, and cross-functional collaboration.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.