Job Details:
Quality Engineer - Electronics FDA Regulated
Summary of Position with General Responsibilities:
This position is responsible for the Quality Assurance and Control processes within the Engineering organization. This position will be responsible to review the output of Servicing and Complaint Investigation activities to ensure that the resulting work complies with all regulatory requirements, as well as facility, divisional, and corporate objectives.
Essential Job Functions:
Ensure that Complaint Investigations and Servicing activities are thorough, complete, self-explanatory, and completed in a timely manner.
Assist technicians in establishing investigation criteria and, as needed in troubleshooting returned products to identify root causes of failures
Assist in quality investigations with Divisional Field Assurance and Engineering to identify causes of service and complaint trends.
Provide ongoing training to Service staff on regulatory requirements associated with complaint investigations
Review and approve completed service records for accuracy
Participate in Product Transfer teams to assist in developing service repair processes for new or transferred products
Participate in the development and review of engineering change orders that impact servicing activities
Work with Engineering to design and implement tooling and fixturing required to perform servicing activities.
Perform DHR, Service History record, and PFMEA reviews in support of complaint investigations
Coordinate complaint investigation activities with divisional Field Assurance
Review and monitor monthly service reports for trends
Prepare monthly reports on Complaint Investigation findings and trends
Additional Job Functions:
Support the goals of the Quality Organization, Continuous Improvement efforts and Cost Improvement Projects.
Other duties as required.
Basic Qualifications:
Excellent technical report writing skills
Strong Root Cause Analysis and Design Of Experiments/Investigation experience as related to Complaint Investigations
A solid understanding of the FDA QSR Quality System Requirements, and the ability to apply the knowledge to comply with goals and objectives.
Strong experience with MS Office Products (Word, Excel, Visio, Project, PowerPoint, Outlook, etc.)
Excellent oral and written communication skills with the ability to communicate with audiences of varying technical skills
A strong ability to prepare written technical plans and reports in support of engineering changes, product or process validations, and failure investigations.
Strong focus on meeting customer needs.
Ability to train/mentor electronic test technicians
Ability to work with cross-functional teams.
Demonstrated strong attention to detail and "do it right the first time” attitude
Additional Desirable Qualifications Skills and Knowledge:
Experience in an FDA regulated environment
Experience in electro-mechanical troubleshooting techniques
Experience in a customer focused service organization
Familiarity with ISO14971 and associated Risk Management Processes
Knowledge of and/or experience with product decontamination and Blood Borne Pathogen exposure controls
Ability to work with and motivate people.
Proven leadership skills in a fast pace environment.
Education and/or Experience:
Bachelors Degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, etc)
3+ years of experience in the manufacture of Electro-Mechanical devices
3+ years experience in FDA regulated Medical Device Manufacturing
Send your resume today
chuck@libertyjobs.com
quality engineer, quality systems, embedded, electronics, medical device