QA Engineer

BBBH16647_1711398379
  • Negotiable
  • Andover, Massachusetts
  • Permanent

QA Engineer

Introduction: Are you passionate about ensuring the highest quality in medical device development? Do you thrive in an environment that values precision and compliance? We have an exciting opportunity for a seasoned Quality Assurance Engineer who is ready to make a significant impact on the forefront of medical technology.

About Us: Join a dynamic team at the forefront of innovation in medical devices. We are a leader in the industry, committed to pushing boundaries and improving patient outcomes. Our dedication to quality and excellence has positioned us as a key player in the medical technology landscape.

About the Role: As a QA Engineer, you will play a pivotal role in ensuring the success of our New Product Introduction (NPI) and sustaining projects. Reporting to the Senior Director, Quality Assurance, you will be responsible for overseeing the design control process, ensuring it aligns seamlessly with customer expectations and regulatory requirements.

What We Can Offer You:

  • Innovative Work Environment: Immerse yourself in cutting-edge technologies and collaborate with a talented team.
  • Professional Growth: Expand your skill set and advance your career in a company that values continuous learning.
  • Competitive Compensation: We recognize and reward top talent with a competitive salary and benefits package.

Key Responsibilities:

  • Design Control Oversight: Manage the overall health of the design control process, guaranteeing compliance with quality standards and regulatory requirements.
  • Collaboration: Partner with Development and Engineering teams to ensure effective implementation of design control requirements.
  • Documentation Review: Review and approve design control-related Change Notices (CNs) to maintain accuracy and compliance.
  • Process Improvement: Develop and implement processes to ensure consistent adherence to internal requirements and external regulations.
  • Subject Matter Expertise: Act as a subject matter expert on design control processes and Quality Engineering, covering Risk Management, Test Method Validation (TMV), Statistics, Reliability Engineering, and Process Validation (PV).
  • Compliance: Provide guidance on FDA compliance and procedures, ensuring adherence to 21 CFR Part 820, ISO 13485, and ISO 14971.

Requirements:

  • Education: BS in Engineering or a related technical discipline.
  • Experience: 8 years of relevant experience in medical device development control.
  • Regulatory Knowledge: Working knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971.
  • Statistical Analysis: Practical experience using Minitab or other statistical analysis tools.
  • Communication: Ability to communicate ideas clearly and concisely.
  • Detail-Oriented: Highly detail-oriented with strong organizational and prioritization skills.

Education:

  • Degree: BS in Engineering or a related technical discipline.

Don't miss this chance to join a company that values your expertise and commitment to quality. Elevate your career as a QA Engineer in the dynamic field of medical device development. Apply now and be part of our journey to redefine possibilities in healthcare.

Charlie Moran Recruitment Consultant

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