Quality Engineer 3

Bedford, Massachusetts Permanent USD120,000 - USD135,000 per year
  • Industry Leader in Healthcare
  • Commitment to Quality & Innovation

About Our Client

My client is a globally renowned company recognized for its exceptional contributions to the healthcare industry, particularly in the field of eye health. With a legacy spanning over 160 years, the company has earned a reputation for excellence, innovation, and unwavering commitment to improving vision and overall ocular health.

My client's portfolio of products includes a wide range of innovative contact lenses, eye care solutions, and surgical devices, all designed to meet the diverse needs of patients and healthcare professionals worldwide. The company's dedication to research and development has led to groundbreaking advancements in vision correction technology, revolutionizing the way people see and experience the world. My client's quality standards are second to none, with stringent manufacturing processes and rigorous testing procedures ensuring the safety, efficacy, and reliability of its products.

Beyond its commitment to innovation and quality, they also prioritizes corporate social responsibility, actively engaging in initiatives to improve access to eye care and promote sustainable practices. As a trusted leader in the industry, my client continues to set the benchmark for excellence in eye health, empowering individuals to live fuller, healthier lives through better vision and enhanced ocular well-being.

Job Description

  • Conduct quality assessments and inspections of manufacturing processes, materials, and finished products to ensure compliance with regulatory standards and company specifications.
  • Implement and maintain quality control procedures, including sampling plans, inspection criteria, and testing protocols, to monitor and evaluate product quality throughout the production lifecycle.
  • Investigate and resolve quality issues by performing root cause analysis, implementing corrective and preventive actions, and documenting findings in accordance with regulatory requirements.
  • Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to drive continuous improvement initiatives aimed at enhancing product quality and reliability.
  • Support new product development activities by participating in design reviews, validation testing, and risk assessments to ensure quality requirements are met.
  • Develop and maintain quality documentation, including standard operating procedures, work instructions, and quality records, to ensure traceability and compliance with regulatory standards.
  • Provide training and guidance to production personnel on quality procedures, best practices, and regulatory requirements to ensure adherence to quality standards.
  • Lead quality-related projects and initiatives, such as process optimization, supplier quality improvements, and CAPA (Corrective and Preventive Action) implementation, to drive operational excellence and mitigate quality risks.
  • Monitor and analyze quality metrics and trends to identify opportunities for improvement and drive data-driven decision-making processes.
  • Act as a liaison with regulatory agencies and auditors during inspections and audits, ensuring compliance with applicable regulations and standards.

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: 5-10 years of experience working within Quality Engineering
  • 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.
  • 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
  • Annual Bonus
  • Strong Healthcare & Wellness Benefits
  • Retirement Plans
  • Professional Development
  • 401k Match
Cian Troy
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Job summary

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