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.
• 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.

Qualifications

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

Pay / Compensation

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.

About the Role

We are the people behind the people who keep saving lives.

Benefits

Details about benefits are not specified in the provided job posting.

Schedule

Details about schedule are not specified in the provided job posting.