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 benefits

Dental benefits

Vision benefits

Wellness programs

Life insurance

Disability insurance

Retirement matching

Paid time off

Job summary

RXinsider LTD. is seeking an experiencedQuality Assurance professional to lead defect management, design verification, and post-market changes. You will coordinate cross-functional teams, maintain the DMR, and ensure compliance with ISO 9001 and ISO 13485.

The role involves identifying quality issues, leading safety risk assessments, and driving MDR-related activities. The candidate should have a strong background in SDLC, SAP/PLM practices, and proven leadership in regulated environments with

Qualifications

• Advanced knowledge of QMS documentation and regulatory standards (ISO 9001, ISO 13485).
• Proficiency with quality investigation tools and statistical analysis.
• Understanding of SDLC and defect tracking platforms like Jira.
• Experience leading cross-functional teams and managing product changes.
• Strong project management, prioritization and leadership abilities.
• Excellent problem solving and communication skills.

Responsibilities

• Lead defect management and escalation processes for timely resolution.
• Review and approve design, verification, and validation protocols.
• Manage cross-functional change processes with thorough documentation.
• Maintain the Device Master Record (DMR) post-market changes.
• Ensure design outputs align with inputs and comply with protocols.
• Coordinate with engineering, product management and quality early in design.
• Triage quality issues and perform root cause analyses for corrective actions.
• Lead post-production safety risk assessments and mitigations.
• Drive MDR processes and coordinate with regulators and recalls.
• Present safety and risk updates to the Safety Risk Management Board.
• Lead quality improvement projects and implement data-driven metrics.
• Maintain ISO 9001 and ISO 13485 compliance; manage CAPA.

Skills

QMS knowledge

Regulatory standards

SDLC understanding

Cross-functional leadership

Project management

Problem solving

Communication skills

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.)