Compunnel Inc. | Quality Engineer

7 days ago

tewksbury, United States Compunnel Inc. Full time

Exciting Opportunity for a Quality Systems Professional

Are you passionate about ensuring high standards in quality management systems? Do you thrive in a collaborative environment where your expertise drives continuous improvement? We are looking for a detail-oriented and proactive Quality Systems Specialist to join our team and play a key role in optimizing our Quality Management System (QMS) and ensuring regulatory compliance.

Key Responsibilities:

  • Document & Process Excellence: You will be at the forefront of generating, reviewing, and maintaining division-level quality documents such as procedures, work instructions, job aids, and certificates of conformance, all while ensuring strict compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.
  • Change Control & Process Optimization: Lead the initiation of Change Controls and Document Change Requests to keep our procedures up to date. You will collaborate closely with manufacturing and distribution teams to assess and implement process changes efficiently.
  • Audit Leadership: Take the lead in conducting internal audits, ensuring our systems are operating smoothly and in full compliance with all regulations.
  • Continuous Improvement: Use your expertise in root cause analysis to drive corrective and preventive actions (CAPAs) and spearhead continuous improvement initiatives to enhance the efficiency and effectiveness of our QMS.
  • Regulatory Support: Be an essential part of our team by supporting regulatory activities and contributing to quality system projects and metrics analysis.

What We’re Looking For:

  • Educational Background: A Bachelor’s Degree with at least 3 years of relevant experience (preferably in a manufacturing environment). Alternatively, a Master’s Degree with 1+ years of work experience is also welcomed.
  • Experience & Skills:
  • Proven experience with ETQ software is highly preferred.
  • Strong proficiency in Microsoft Office.
  • In-depth knowledge of ISO 13485 and 21 CFR 820 Quality Management Systems.
  • Hands-on experience or training as an Internal Auditor.
  • A keen eye for detail and accuracy.
  • Comfort applying basic mathematical concepts (percentages, ratios, etc.) in practical scenarios.
  • Ability to work seamlessly across different departments and collaborate with external consultants.

What We Offer:

  • Collaborative Work Environment: Work with a diverse team of professionals dedicated to maintaining the highest standards of quality.
  • Growth Opportunities: Take ownership of projects, develop your skills, and grow within a dynamic company.
  • Impact: Be a key player in enhancing our quality processes, ensuring compliance, and driving positive change across the organization.

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