Sr. Quality Engineer

RXinsider LTD.; Cranberry Township, Northern (Butler County, KY); Hybrid; USD 80,000 - 115,000; Full time

Benefits offered by this job

Medical, dental and vision

Voluntary wellness program

Employee assistance programs

Life insurance

Disability insurance

Retirement plans with matching

Paid time off

Job summary

RXinsider LTD. in the United States seeks a Quality Assurance professional to lead change control, post-market surveillance, and regulatory compliance for medical devices.

You will drive QA programs, perform root-cause analyses, coordinate with engineering, product management and quality teams, and ensure ISO 9001 and ISO 13485 standards compliance with up to 25% travel.

Qualifications

• Bachelor’s degree in Engineering or Science; required.
• 5+ years in Engineering, Quality or related technical field.
• Experience in regulated environments (ISO 9001, ISO 13485 or FDA QMSR).
• Experience in product development/maintenance and process development.

Responsibilities

• Lead defect management and engineering escalation processes.
• Drive design/verif/validation review and lifecycle processes.
• Maintain Device Master Record (DMR) during post-market changes.
• Coordinate cross-functional teams on product changes and CAPA.
• Lead safety risk assessments and MDR process coordination.
• Present updates at Safety Risk Management Board Meetings.

Skills

QMS documentation

Regulatory standards ISO 9001 13485

Quality investigation tools

Statistical analysis (SPC, Six Sigma)

SDLC understanding

Cross-functional leadership

Project management

Communication

Leadership

Education

Bachelor’s degree in Engineering or Science

Tools

Jira

Job description

Responsibilities

Change Control and Design

• Lead the execution of defect management and engineering escalation processes, ensuring timely identification, resolution, and reporting of product issues.
• Drive the review and approval of design and service verification and validation protocols, with a focus on product changes and lifecycle processes.
• Manage cross-functional teams in product change control processes and ensure comprehensive documentation of product modifications.
• Take ownership of maintaining and updating the Device Master Record (DMR) for assigned product lines during post-market changes.
• Ensure alignment of design outputs with inputs, proactively addressing discrepancies and ensuring compliance with internal protocols.
• Act as the lead liaison between engineering, product management, and quality teams to integrate quality considerations early in the product design phase.

Field, Customer And Safety

• Independently process and triage out-of-box quality issues, conducting root cause analyses and collaborating with teams to drive corrective actions.
• Lead post-production safety risk assessments and implement solutions to mitigate safety concerns.
• Drive the Medical Device Reporting (MDR) process, coordinating with regulatory bodies and managing field actions and recalls.
• Present safety and risk management updates during Safety Risk Management Board Meetings, with responsibility for product-specific risks.

Compliance And Continuous Improvement

• Lead quality improvement projects aimed at optimizing processes, reducing defects, and enhancing customer satisfaction.
• Ensure adherence to ISO 9001, ISO 13485, and other relevant regulatory standards, acting as a subject matter expert for compliance.
• Implement and analyze quality metrics, creating reports to monitor process performance and drive data-driven improvements.
• Conduct internal audits and manage corrective and preventive actions (CAPA) to ensure continued compliance and improvement.

Required Knowledge And Skills

• Advanced knowledge of QMS (Quality Management System) documentation and regulatory standards (ISO 9001, ISO 13485).
• Proficiency in quality investigation tools (e.g., Fishbone diagrams, 5 Whys) and statistical analysis (e.g., SPC, Six Sigma).
• Understanding of software development lifecycle (SDLC) and experience in defect tracking platforms like Jira
• Experience in leading cross-functional teams and managing product changes from initiation through post-market stages.
• Strong project management skills and the ability to manage multiple priorities effectively.
• Excellent problem-solving, communication, and leadership abilities.

Basic Qualifications

• Bachelor’s degree in Engineering or Science discipline
• 5+ years in Engineering, Quality or related technical professional experience
• Experience in product development and/or maintenance
• Experience in process development
• Experience working in a regulated environment (i.e. ISO 9001, ISO 13485 or FDA QMSR)

Preferred Qualifications

• Experience working with complex electro-mechanical systems
• Experience working with Cloud software and AI/ML

Work Conditions

• Office Environment
• May travel up to 25%

Base Compensation: $80,000.00 to $115,000.00
(Actual compensation is subject to variation due to such factors as location, education, experience, and skillset. We offer a comprehensive benefits package, including medical, dental and vision plans covering eligible US employees and dependents, voluntary wellness and employee assistance programs, life insurance, disability, retirement plans with matching, and paid time off.)