Sr. Quality Engineer

Position Summary:

We are seeking a Senior Quality Engineer to join our Quality Assurance team within a fast-paced, FDA-regulated medical device environment. This role is responsible for supporting design controls, risk management, and quality system processes to ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable global regulatory standards. Experience with Windchill PLM is required, as this role will involve direct interaction with product lifecycle data and document control systems.

Key Responsibilities:

• Provide quality engineering support throughout the design and development lifecycle, including design verification/validation, risk management, and design reviews.

• Lead or support the creation and maintenance of Design History Files (DHF) and Device Master Records (DMR).

• Ensure document control and change management activities are executed accurately within Windchill PLM.

• Manage and review engineering change orders (ECOs) and ensure alignment with quality and regulatory requirements.

• Participate in CAPA, nonconformance investigations, and root cause analysis.

• Lead and support internal and external audits, including FDA, ISO, and notified body audits.

• Maintain and improve quality systems in alignment with QMS requirements.

• Collaborate cross-functionally with R&D, Regulatory, Manufacturing, and Supply Chain teams.

• Support supplier quality activities, including qualification, audits, and performance monitoring.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.

• Minimum 5+ years of experience in a Quality Engineering role within a medical device or other regulated industry.

• Strong proficiency in Windchill PLM—experience managing product lifecycle data and document workflows is essential.

• Deep understanding of ISO 13485, 21 CFR 820, and risk management (ISO 14971).

• Experience with design controls, verification/validation protocols, and root cause analysis tools (e.g., 5 Whys, Fishbone).

• Familiarity with tools such as Jira, TrackWise, or other QMS platforms is a plus.

• Excellent communication, problem-solving, and organizational skills.

Preferred Qualifications:

• ASQ Certified Quality Engineer (CQE) or equivalent certification

• Knowledge of global regulatory requirements (EU MDR, MDSAP, etc.).