Product Quality Engineer

Description

Minimum 1 year working with medical devices or other highly regulated industry, Quality Engineering experience preferred

 Job Title:   Product Quality Engineer         

 Job Summary

• Provide Product Quality Engineering support on risk management and product complaint trending.
•  This role will be responsible for reviewing each complaint record individually and identifying the appropriate risk lines and associated severities from the product's Risk Management File (RMF) that relate to what was reported by the complainant and the results of the investigation.
• In partnership with Product Quality Engineering and Post Market Quality Engineering, the qualified contractor will perform assessments, identify potential updates to the RMF, and perform trend analysis per the applicable quality procedures.

Essential Duties

• Duties are listed in order of greatest importance.  The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.  
• Analyze complaint information and identify hazardous situations and harms reported through complaint information
• Evaluating content in existing Risk Management Files ensuring all hazardous situations and harms reported through complaint information is adequately captured.
• Perform trend analysis using Statistical Process Controls per applicable quality procedures.

Qualifications 

Education   

• BS in, or health care related discipline 

Experience  

• Minimum 1 year working with medical devices or other highly regulated industry, Quality Engineering experience preferred 

Skills 

• Experienced with Quality System Regulations, ISO 13485 and 21 CFR 820.
• Experienced with ISO 14971, Risk Management
• Basic knowledge of risk analysis techniques such as FMEAs
• Basic knowledge of medical terminology and anatomy
• Basic knowledge of engineering and process terminology
• Understanding of statistics including statistical process control (SPC) - Minitab experience preferred
• Detail-oriented and committed to maintaining accuracy and compliance in all tasks
• Accountable and reliable, with a focus on timely communication and issue escalation
• Collaborative team player, open to receiving feedback and contributing to shared goal
•  Ability to effectively work on project teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution
• Ability to appropriately assess written product and project documentation, and ability to effectively communicate assessment

Preferred

• Experience authoring and executing risk assessments
• Working knowledge of ISO14971, 21 CFR 803 and 21 CFR 820 

 Physical Demands

A thorough completion of this section is needed for compliance with legal standards such as the Americans with Disabilities Act. The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

• Sit; use hands to finger, handle or feel objects, tools, or controls.
• Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.