Quality Systems Specialist

Position Summary  

The Quality System Specialist supports activities related to the Oliver quality system standards and ISO 13485:2016.

Primary Responsibilities 

• Oversee the internal complaint process including investigation of root cause, development of corrective action plan and timely closure of complaint.
• Facilitate the maintenance of Visual Quality for the Nonconformance (NCM) and Corrective & Preventative Action (CAPA) process.
• Analyze data and report metrics, categorize internal complaints by work center and shifts.
• Specification review and plate approvals – back-up.
• Perform data collection and analyze data to provide reports to customers with specific requirements.
• Member of Internal Audit Team.
• Assume ownership of First Article Inspection process for customers with specific requirements.

Basic Qualifications 

Education and/or Experience

• Bachelor degree
• 3+ years of quality engineering experience.
• Strong verbal and written communication skills.
• Tech and computer competency with hands-on skills in Word, Excel, MiniTab.

  Preferred Qualifications 

• Knowledge of quality assurance in FDA regulated environments including hands on experience with ISO 13485 and cGMP.
• History of driving results with a sense of urgency, good communications skills, and ability to manage details.
• Excellent listening skills and conflict resolution skills.
• Demonstrated ability to work in partnership with colleagues, superiors and customers.

Working Conditions 

• Prolonged periods of sitting at a desk and working on a computer
• Must be able to lift up to 10lbs.

Special Requirements 

• Ability to travel (US and internationally)
• Ability to work evenings and/or weekends

Disclaimer 

This job description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not intended to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this position.  This job description is subject to change but remains in effect until superseded or canceled in writing by your local Human Resources Representative or the Director of Global Human Resources.