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Senior Quality Engineer

  • Second Street, Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Sr QA Engineer (CAPA) is an experienced professional with wide-ranging skillsets to assist and support with the CAPA System at FMI. The role conducts day to day administration of the CAPA process, coordinating the review, documentation and retention of quality records. The Sr QA Engineer CAPA exercises considerable latitude to prioritize daily activities in a fast-paced environment, monitoring for timely completion of tasks and escalating any potential risks to ensure timely completion of CAPA deliverables. The position coordinates a variety of related tasks, assuming different activities when priorities change and interacting with all departments within FMI to support the effectiveness of the CAPA Quality System.

Key Responsibilities

• Support and maintain the effectiveness and health of the CAPA Quality System.

• Assist CAPA teams with Root Cause Analysis.

• Provide technical writing guidance to ensure CAPA phases are documented accordingly to support the CAPA file.

• Assist with reporting Key Performance Indictors (KPIs).

• Maintain CAPA statuses due to changes in scope; escalate any barriers to CAPA Manager which might affect initiatives.

• Help develop the CAPA process to manage CAPA status, phase due dates, and facilitate extensions and any action item follow-up with owners to ensure all activities are performed timely.

• Review approve CAPA initiations to ensure they meet the criteria of a CAPA.

• Perform periodic trending of CAPAs to identify systemic issues, Action plan approvals, Action Task due dates, and root cause failure modes.

• Manage and maintain CAPA Database for accuracy and consistency.

• Maintain close communication and collaboration with CAPA manager to adjust priorities as needed and ensure that initiatives stay on target.

• Take meeting minutes and participate during CRB (CAPA Review Board) meetings.

• Be responsible for compliance with applicable Corporate and Divisional Policies and procedures.

• Provide CAPA guidance to CAPA Owners/Managers.

• Assist CAPA Manager with general administrative CAPA support.

• Maintain availability to work outside of a regularly scheduled shift.

• Travel domestically up to 10% of the time.

• Other duties as assigned.

Qualifications

Basic Qualifications

• Bachelor of Science degree or equivalent years of experience in technical or engineering discipline

• 5+ years of related professional experience

Preferred Qualifications

• 5+ years of Quality Assurance experience; preferably in the medical device or pharmaceutical industry

• Experience with CLIA/CAP requirements in a laboratory setting

• Knowledge of Root Cause Analysis

• General understanding of CAPA and 21CFR820, Part 11 requirements, and ISO 13485

• Demonstrated Technical Writing Skills/Training

• Proficient in MS Office (i.e. Excel, Word, Power Point, Visio, Outlook, etc.)

• Strong communication skills

• Able to multi-task and manage shifting priorities

• Able to work independently or in a team environment

• Organized with great attention to detail

• Understanding of HIPAA and importance of privacy of patient data

• Commitment to FMI values: patients, innovation, collaboration, and passion

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Internal applicants, please use your FMI email address.

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