Senior Quality Systems Engineer

Strengthen and scale quality systems in a fast-growing medical device environment, leading CAPA, audits, and process improvements. Cross-functional role with visible impact on life-saving technologies.

Client Details

My client is a renowned and innovative medical technology company that has garnered widespread acclaim for its groundbreaking contributions to organ transplantation. The company's flagship product stands as a testament to its commitment to pushing the boundaries of medical science. My client has revolutionized organ preservation by allowing for real-time monitoring and optimization, significantly improving transplant outcomes.

One of my clients' strengths lies in its dedication to quality, with a focus on adhering to stringent regulatory standards such as ISO 13485 and FDA requirements. The company fosters a dynamic work environment that encourages continuous learning and professional growth, making it an attractive destination for individuals passionate about making a positive impact on healthcare. The collaborative culture at my clients facility, coupled with effective communication channels, ensures that employees work seamlessly across cross-functional teams.

My client has played a pivotal role in advancing the field of transplant medicine, enhancing the success rates of life-saving procedures and ultimately improving patient outcomes. Their commitment to innovation, coupled with a mission-driven approach, positions my client as a leader in the quest to address critical challenges in organ transplantation. Overall, my client stands as a beacon of excellence in the medical technology sector, driven by a vision to transform and improve the landscape of healthcare through cutting-edge solutions.

Description

Senior Quality Systems Engineer:

• Lead CAPA program, investigations, and metric reporting
• Write, update, and maintain SOPs and quality documentation
• Support internal and external audits, including EQMS validation
• Identify quality system gaps and implement improvements
• Drive Risk Management, FMEA, and process improvement initiatives
• Provide training and guidance on quality processes across teams
• Collaborate cross-functionally to support scalable, compliant quality systems

Profile

Senior Quality Systems Engineer:

• 5-7+ years in medical device quality systems
• Strong CAPA ownership and problem-solving skills (RCA, DOE, FMEA)
• SOP creation and internal audit experience (certified a plus)
• Experience with EQMS implementation and validation
• Knowledge of 21 CFR Part 820, ISO 13485, EU MDR
• Proactive, results-driven, able to handle multiple priorities
• Strong communication, analytical, and cross-functional collaboration skills

Job Offer

• Base salary $120K-$130K with 7% bonus potential
• Lead impactful quality system improvements in life-saving medical technology
• Work in a mission-driven, collaborative, and transparent environment
• Gain experience scaling QMS from small-company setup to mid-size systems
• Opportunity to work cross-functionally on audits, CAPA, EQMS, and process improvements
• Highly visible role where contributions have measurable impact
• Hands-on, dynamic work environment with professional growth opportunities

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.