Main Purpose of Job:

Develop, establish, and maintain quality engineering methodologies, systems and practices in accordance with FDA QSR’s and ISO 13485 to support the production and development of disposable and durable medical device systems, including software.

Main Job Duties & Responsibilities:
Perform or coordinate failure investigations and prepare failure investigation reports.
Recommend, plan and lead assigned corrective and preventive actions for continuous improvement.
Participate in complaint investigations, complaint closure, analysis of complaint trends, and other complaint department activities as needed.
Conduct nonconforming material investigations and dispositions as required.
Support design and process changes for current product and provide input and approval of qualification protocols and reports.
Assist product development teams with activities such as design requirements, verification testing methods, reliability analysis, protocols and reports, and help ensure the team is in compliance with applicable processes and regulations.
Lead or participate in risk management activities following ISO 14971 with tools appropriate for various stages of the product lifecycle including FMEA, PFMEA, and Use Error Hazard analysis.
As assigned, participate or lead electrical compliance certification process for IEC 60601-1 third edition including ISO 62304 software compliance activities.
Prepare and analyze quality metrics as needed for Quality Management Reviews or as deemed necessary to assist in identification of failure trends.
Participate in the creation, implementation, and teaching of new or improved quality system processes.
Responsible for QA activities such as material biocompatibility testing and sterilization validations as assigned.
Support equipment and process validation (IQ/OQ/PQ) by participating in the development of studies and validation protocols to assess manufacturing capability/reliability.

Qualifications:
BS degree in Engineering or equivalent degree/experience
Minimum three (3) years quality engineering experience in the medical device industry.
Direct experience with FDA QSR, MDD & ISO 13485 compliance for manufacture of medical devices
Working knowledge of Design Controls and ISO 14971 Risk Management best practices
Strong verbal communication skills and effective writing skills required
Ability to excel in a team oriented environment
Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), or Six Sigma Black Belt (CSSBB) status desired