Sr. Quality Engineer #3812

2 days ago

Boston, Massachusetts, United States Enhanced Compliance Inc. Full time

About ECI

ECI's mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About the role

The quality system resource will support clients in the remediation of their internal audit process.

What you'll do

  • Assess and remediate the existing Internal Audit System to align with the requirements of ISO 13485:2016 and 21 CFR 820.
  • Review the previously identified deficiencies of current audit procedures, tools, documentation, and execution.
  • Support the execution of CAPAs associated with the identified deficiencies.
  • Develop and implement a comprehensive audit remediation plan addressing compliance deficiencies.
  • Update standard operating procedures (SOPs), work instructions, audit schedules, checklists, and templates.
  • Define audit scope, criteria, frequency, and methods in line with risk-based approaches and regulatory expectations.
  • Provide training and guidance to internal auditors and cross-functional teams on updated audit practices.
  • Ensure robust audit trail documentation and corrective/preventive action (CAPA) linkage.
  • Collaborate with cross-functional teams (RA, QA, Manufacturing, R&D) to ensure system-wide alignment and buy-in.

What you will bring

  • Minimum of 5+ years direct experience in medical device industry
  • Education: Bachelor's Degree in Biomedical/ Mechanical/ electrical engineering or equivalent is required
  • Experience executing CAPA activities
  • Demonstrate Strengths in - Identifying creative and efficient solutions to engineering challenges, Translating customer requirements into workable product ideas and solutions. Good analytical and problem-solving skills.
  • Broad and in-depth regulatory knowledge in medical device (Class II and III medical devices)

ECI is an equal opportunity employer.

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.

At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.

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