SENIOR QUALITY ASSURANCE ENGINEER

MedAcuity•Westford, MA

9d•$125,000 - $150,000•Hybrid

About The Position

The Senior Quality Assurance Engineer will work closely with internal and external project teams, cross-functionally throughout the project life cycle primarily in the MedTech space. The candidate will be adept at remediating legacy quality systems, and ensuring consistent, compliant project execution. They will be responsible for auditing processes, developing and improving QMS procedures, and ensuring alignment with regulatory and industry standards.

Requirements

8+ years of professional background in a similar QA / Regulatory function within a medical device environment with a focus on software process compliance.
Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 9001, IEC 62304, IEC 81001-5-1, and Risk Management standard ISO 14971.
Experience with QMS improvements, documentation authoring, and DHF gap analysis.
Production expertise in software development and Quality Assurance in medical device, pharmaceutical, or related regulated fields.
Exposure to working in a professional services environment, communicating with primary stakeholders from internal consultancy and client management.
Proficiency with Root Cause analysis and Corrective Actions (CAPAs).

Nice To Haves

Certified Quality Engineer preferred and / or Auditor Certification desired.
Proficiency in cyber-security regulations and its integration with risk management activities.
Direct experience with requirements development, analysis, verification, and validation.
Prior work history with software tools such as eQMS and document control systems such as Master Control, Arena, Veeva, etc.

Responsibilities

Contribute to or lead assessment engagements for medical device products in terms of completeness, conformance, and compliance as it relates to a Quality Management System (QMS) and associated QMS elements and Design and Development File and associated design artifacts.
Author, remediate, and improve QMS elements including SOPs and Wis as well as project specific documents such as Quality Management Plans, Verification and Validation Plans, Risk Management Plans, and CAPAs.
Partner with project teams and clients to ensure conformance to requirements of 21 CFR Part 820, ISO 13485 with particular focus on Design Controls, Risk Management (per ISO 14971), Production, Service Controls, Product Privacy, and Security.
Provide teams with technical support for QA / Regulatory compliance activities.
Participate in CAPA processes, risk analysis, complaint management, and internal auditing.
Identify, develop, and execute process improvements, lead continuous improvement initiatives and drive changes cross-functionally.
Develop and deliver effective training materials tailored to engineering, quality, and leadership audiences.
Support internal as well as external audits and other Quality Assurance functions.