Senior Quality Engineer; On site

Responsibilities

• Maintain and improve the effectiveness of the Quality Management System in compliance with applicable regulatory and quality standards.
• Support quality system processes including:
  • Corrective and Preventive Actions (CAPA)
  • Nonconforming Material Reports (NCMR)
  • Complaint Handling
  • Internal Audits
  • Document Control
  • Training Compliance
  • Change Control
• Review, investigate, approve, and monitor quality records to ensure timely closure and regulatory compliance.
• Identify quality system gaps and implement corrective actions to improve compliance and operational effectiveness.
• Serve as a key participant during external audits and inspections conducted by regulatory agencies, notified bodies, customers, and certification organizations.
• Partner with Manufacturing and Engineering teams to address product and process quality issues.
• Drive root cause investigations and risk‑based decision making for quality events.
• Escalate issues through the Nonconformance and CAPA processes when appropriate.
• Support process validation, product transfers, and continuous improvement initiatives.
• Participate in product risk management activities, including Distributed Product Risk Assessments (DPRA) and risk mitigation efforts.
• Monitor and analyze quality metrics to identify trends, risks, and opportunities for improvement.
• Prepare and present quality performance data during Management Review meetings.
• Lead or support medium‑complexity projects focused on process improvement, compliance enhancement, and operational excellence.
• Drive initiatives that improve product quality, process efficiency, and customer satisfaction.
• May provide functional leadership or supervision of technician‑level personnel as assigned.
• Communicate significant quality, compliance, and business‑related issues to management in a timely manner.
• Ensure compliance with all applicable federal, state, local, and international regulations, company policies, and quality procedures.
• Support Environmental Health & Safety (EHS) requirements and promote safe work practices.
• Perform additional duties and responsibilities as assigned.

• Requires Engineering Bachelors Degree plus 5+ years of relevant experience.
• Expertise in the FDA Medical Device Quality System Regulation, MDR, MDSAP and ISO 13485

The expected pre‑tax pay rate for this position is $95,000 ‑ $120,000 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job‑related knowledge and location.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work‑authorized visa.

Cordis is a proud equal‑opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity includes race, gender identity, age, disability status, veteran status, sexual orientation, religion, and many other parts of one's identity. All our teammate's points of view are key to our success, and we believe inclusion is everyone's responsibility.

Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.