Senior Quality Engineer

Methuen, Massachusetts Permanent USD100,000 - USD120,000 per year
  • Innovation & Impact on Healthcare
  • Professional Growth and Learning Opportunities

About Our Client

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.

Job Description

  • Ensure Compliance: Oversee and ensure compliance with relevant medical device regulations, including ISO 13485 and FDA standards, to uphold the highest quality standards in organ preservation and transplantation technologies.
  • Quality Management: Implement and maintain robust quality management systems to monitor and control processes throughout the product lifecycle, contributing to the overall quality assurance framework.
  • Risk Management: Utilize effective risk management methodologies to identify, assess, and mitigate potential quality risks associated with my clients' products.
  • Documentation Control: Manage and maintain accurate and up-to-date documentation related to quality processes, ensuring accessibility and adherence to regulatory requirements.
  • Product Testing and Validation: Plan, coordinate, and execute product testing and validation processes to ensure the reliability and performance of my clients' medical technologies.
  • Root Cause Analysis: Conduct thorough investigations into quality issues, employing root cause analysis methodologies to identify the underlying factors and implement corrective and preventive actions.
  • Cross-Functional Collaboration: Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to address quality-related challenges and foster a culture of continuous improvement.
  • Audits and Inspections: Prepare for and participate in internal and external audits, inspections, and assessments to verify compliance with regulatory standards and identify areas for improvement.
  • Supplier Quality Management: Collaborate with suppliers to ensure the quality of incoming components and materials, implementing effective supplier quality management processes.
  • Training and Development: Provide training and guidance to internal teams on quality-related processes, standards, and procedures, contributing to the ongoing professional development and awareness of quality requirements within the organization.

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.

The Successful Applicant

  • Educational Background: B.S. Degree (Engineering or Technical)
  • Experience: 4-5 years of experience working within Quality Engineering
  • Class 3 Device Expertise: Proven track record of working with Class 3 medical devices, demonstrating a deep understanding of the heightened regulatory requirements and quality standards associated with these complex and critical healthcare products.
  • ISO 13485 Proficiency: Extensive experience and proficiency in implementing and maintaining ISO 13485 quality management systems, ensuring adherence to international standards in the development and manufacturing of medical devices.
  • Clean Room Experience: Demonstrated hands-on experience in working within clean room environments, showcasing the ability to maintain stringent cleanliness and hygiene standards critical to the production of high-quality medical devices.
  • Regulatory Compliance: Strong familiarity with FDA regulations governing medical devices, with a history of successful interactions with regulatory bodies and a proactive approach to ensuring compliance in all quality-related aspects.
  • Risk Management Mastery: Adept at applying advanced risk management methodologies, particularly in the context of Class 3 medical devices, to identify, assess, and mitigate potential risks throughout the product lifecycle.
  • Root Cause Analysis Skills: Proven ability to conduct thorough root cause analysis to identify and address quality issues effectively, contributing to a culture of continuous improvement within the organization.
  • Documentation Excellence: Skilled in managing and organizing comprehensive documentation related to quality processes, ensuring accuracy and compliance with regulatory requirements for Class 3 medical devices.
  • Cross-Functional Collaboration: Strong interpersonal and communication skills, with a successful history of collaborating seamlessly with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to address quality challenges.
  • Audit Preparedness: Experience in preparing for and participating in audits, inspections, and assessments related to Class 3 medical devices, demonstrating a commitment to maintaining the highest standards of quality and regulatory compliance.
  • Continuous Learning and Adaptability: Demonstrates a commitment to continuous learning, staying updated on industry trends, advancements, and evolving regulatory requirements in the realm of Class 3 medical devices and clean room manufacturing. Additionally, showcases adaptability to the dynamic nature of the medical technology industry.

What's on Offer

  • Competitive Compensation
  • Strong Healthcare & Wellness Benefits
  • Retirement Plans
  • Professional Development
  • 401k Match
Cian Troy
Quote job ref

Job summary

Engineering & Manufacturing
Sub Sector
Quality, Technical
Industrial / Manufacturing
Contract Type
Consultant name
Cian Troy
Job Reference