EXALTA Group · 15 hours ago
Quality Engineer
Bethlehem, PA
Full-time
Onsite
Mid Level
3+ years expEXALTA Group is focused on ensuring the quality of medical devices through a robust Quality Management System. The Quality Engineer will support design quality and compliance with regulatory requirements while collaborating with various departments to maintain effective documentation and continuous improvement initiatives.
Health CareLife ScienceManufacturingMedical DevicemHealth
Responsibilities
Provide Quality Engineering support with a primary focus on design controls and design quality activities
Review design documentation, specifications, and changes to identify quality and regulatory risks
Participate in design reviews and provide Quality input aligned with ISO 13485 and ISO 14971
Support risk management activities, including DFMEA and risk-benefit assessments
Support verification and validation activities through review of protocols, reports, and acceptance criteria
Support nonconformances, investigations, and CAPAs
Contribute to other Quality Engineering activities as needed, including complaint investigations, post-market trending, internal audits, and continuous improvement initiatives
Collaborate with Supplier Quality to support design and specification alignment
Maintain accurate and compliant quality records and documentation within the Quality Management System
Support regulatory and customer audits by providing design-quality and Quality Engineering support
Qualification
Required
Bachelor's degree in Engineering, Quality, or a related technical discipline
3+ years of experience in a regulated medical-device environment
Working knowledge of ISO 13485, including design controls and risk management (ISO 14971)
Experience supporting design reviews, design changes, and quality documentation
Proficiency with quality tools such as DFMEA, root cause analysis, and CAPA
Strong communication skills and the ability to collaborate across cross-functional teams
Working knowledge of GD&T
Preferred
ASQ Certified Quality Engineer (CQE) or equivalent certification
Experience supporting orthopedic, implantable, or Class II/III medical devices
Familiarity with DHF, DMR, and technical documentation
Experience contributing to supplier quality activities and specification alignment
Exposure to Six Sigma, Lean methodologies, or DOE
Experience working within an electronic Quality Management System (eQMS)
Company
EXALTA Group
Born from the fusion of Intech, Tyber and Resolve, EXALTA Group is a global solutions provider for the MedTech industry.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
$0.23MKey Investors
National Science Foundation
2025-01-14Acquired
2019-03-12Grant· $0.23M
2013-11-26Seed
Leadership Team
Jeff Tyber
Chief Executive Officer and Founder
David Hannah
Chief Technology Officer
Recent News
2025-12-15
Company data provided by crunchbase