Lead Quality Systems Engineer

2 weeks ago


Beverly, Massachusetts, United States Quanta Dialysis Technologies Full time
Job Overview

Position Title: Senior Quality Systems Engineer

Company: Quanta Dialysis Technologies Inc.

Location: Remote/Hybrid

Role Summary:

The Senior Quality Systems Engineer is accountable for overseeing the Quality Management System (QMS) at Quanta Dialysis Technologies. This role entails ensuring compliance with various regulatory standards, including ISO13485, MDSAP, and MDR, while actively participating in quality assurance initiatives.

Key Responsibilities:

  • Provide expert support for both ongoing and new development projects related to Quality Systems.
  • Assist in the enhancement and maintenance of the Quality Management System.
  • Lead the creation and revision of Standard Operating Procedures (SOPs) and Work Instructions (WIs) for biomedical equipment.
  • Facilitate Management Review meetings by supplying relevant Quality data.
  • Prepare and present routine reports on Key Process Indicators (KPIs) for management discussions.
  • Maintain and update quality system databases as assigned.
  • Analyze quality data and generate periodic reports to identify trends.
  • Review and approve Change Requests pertaining to Quality Assurance.
  • Oversee the Employee Training matrix to ensure proper training assignments during onboarding.
  • Conduct quality assurance activities to meet QMS KPI metrics, including drafting and reviewing change requests and addressing product non-conformities.
  • Support the Monthly Corrective Action Board meetings.
  • Guide Quality functions across various manufacturing sites, including support for CAPA and Change Control processes.
  • Assist in External Regulatory Audits.
  • Plan and execute Internal Audits as per the established schedule.
  • Manage Supplier Quality Metrics and oversee Supplier Agreements.
  • Conduct audits for critical suppliers and process non-conforming material reports.
  • Ensure that targets related to QMS KPIs are monitored and achieved.

Qualifications:

A Master's degree in Biomedical Engineering or a related discipline is required, along with three years of relevant experience.

Required Experience:

  • Familiarity with FDA Quality System Regulations and ISO standards.
  • Knowledge of Regulation 21 CFR Part 820 and international quality standards such as ISO 13485 and MDR.
  • Experience with qualification processes including First Article Inspection and FMEA.
  • Proficiency in developing and executing validation strategies (IQ, OQ, PQ).
  • Understanding of statistical process control concepts.
  • Experience in Supplier qualifications and managing an Approved Supplier List.
  • Knowledge of CAPA, Deviations, Non-conformance, and Complaints.
  • Ability to assess Manufacturing and Design changes and support their implementation.

Work Arrangement:

This position allows for hybrid remote work, with the expectation of living within a reasonable commuting distance. Occasional travel may be required for various work sites.



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