Quality Engineer

5 days ago

Bedford, United States Pragmatic Full time

Hybrid Quality Engineer – Make an Impact in Medical Devices



Are you ready to shape the future of medical devices? Join our team as a Quality Engineer and play a vital role in ensuring our life-changing products meet the highest industry standards.


Why Join Us?

Join a dynamic team where you’ll have the versatility to take ownership of multiple responsibilities within a cross-functional quality system. Your work will have a meaningful impact, contributing to life-enhancing medical device products that meet the highest industry standards. This role also offers opportunities for professional growth, allowing you to develop and refine your expertise while tackling challenging and rewarding projects.


What You’ll Do

  • Champion Quality Systems: Implement and maintain robust quality management systems in compliance with cGMP, CMDR, ISO 13485, and EU MDR standards.
  • Collaborate and Lead: Represent quality on cross-functional project teams and drive sustaining engineering projects.
  • Inspect and Verify: Conduct quality control inspections to ensure products meet specifications, oversee lot release testing, and perform detailed documentation reviews.
  • Audit and Analyze: Support internal and supplier quality audits while executing and leading risk management activities.
  • Drive Continuous Improvement: Lead post-market surveillance programs, monitor product performance, and refine quality processes through data-driven solutions.


Who You Are

  • Qualified Expert: Hold a bachelor’s degree in a scientific or engineering discipline with experience in regulated industries, ideally in the medical device sector.
  • Certified Professional: A quality auditor certification or equivalent experience in quality functions is a plus.
  • Analytical Innovator: Possess strong problem-solving skills with a focus on root cause analysis and technical assessments.
  • Team Player: Exhibit exceptional interpersonal and communication skills with a collaborative mindset.
  • Detail-Oriented Achiever: Demonstrate meticulous attention to detail and a commitment to excellence in every aspect of your work.
  • Regulatory Proficiency: Well-versed in FDA, ISO 13485, and EU MDR standards, with a mastery of quality principles and risk management strategies.
  • Growth-Oriented: Have a proactive attitude with enthusiasm for learning and continuous improvement.


What to Expect

  • On-Site and Hybrid Work: Begin with full-time, in-office training and team integration during the first three months. Afterward, transition to a hybrid schedule with 1-2 remote days per week.
  • Comprehensive Training: Work closely with the team to master the quality system and operational processes, ensuring you’re set up for success.
  • Collaborative Environment: Engage with cross-functional teams to foster strong relationships and support the seamless execution of quality initiatives.

This is your chance to be part of a team committed to quality and innovation in the medical device industry. Apply today and bring your expertise to a role where your contributions will truly make a difference.

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