Quality Engineer

The Quality Engineer plays a key role in supporting the organization's Quality Management System, with a primary focus on design quality and design controls, while also contributing to other Quality activities across the product lifecycle. This position supports compliance with ISO 13485, FDA 21 CFR 820, EU MDR, and MDSAP requirements, ensuring that medical devices are developed, maintained, and improved in alignment with regulatory and patient safety expectations.

The role partners closely with R&D, Regulatory Affairs, Supplier Quality, and Quality Systems to apply risk-based thinking, maintain compliant documentation, and support investigations, continuous improvement, and design-related initiatives. While design quality is the primary emphasis, this role provides broader Quality Engineering support as needed to ensure system effectiveness and compliance across Exalta's global organization.

Minimum Qualifications

• Bachelor's degree in Engineering, Quality, or a related technical discipline.
• 1+ 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 Qualifications

• 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).

Key Responsibilities

• Provide Quality Engineering support with a primary focus on sustaining quality engineering.
• 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.

Skills & Competencies

The Quality Engineer demonstrates strong risk-based thinking, attention to detail, and regulatory awareness. Success in this role requires the ability to balance deep quality expertise with flexibility to support broader Quality initiatives. Strong written and verbal communication skills are essential for working effectively across technical, regulatory, and Quality teams. A proactive mindset and commitment to compliance, continuous improvement, and patient safety are critical.