Quality Assurance Specialist

Role Overview

• The Quality Specialist, Compliance is responsible for maintaining the ongoing compliance of the Quality Management System.
• Responsible for the administration of the Document Management system on site including coordination of all document change request activities for their nominated area of responsibility.
• Provide training and analytical support in the operation of the relevant GMP systems (MasterControl, SAP etc.).
• Responsible for supporting the onboarding of new hires including participation in the Induction Program and Annual GMP Training.
• Perform data analysis and reporting of Quality System Metrics internally and globally.
• Function as Sub Administrator for the site Quality Event Management System to manage and maintain traceable, accountable Quality Records in compliance with Corporate Guidelines.
• Provide Quality document control oversight on documentation and reports.
• Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards.
• Responsible for management of Systems Training – developing, scheduling, and performing.
• Responsible for management of Document Management Training on site – developing, scheduling, and performing.
• Support generation of data for Management Review.
• Management of Site Metrics generation (weekly and monthly) including reporting out Globally.
• Participate in Internal Audit Program.
• Support in the preparation and hosting of Third-Party Audits including audit training and control room set up.

Requirements

• Associate’s degree in engineering (industrial, chemical), manufacturing or business administration
• Minimum: 2-years of experience in plastics injection molding and/or blow molding.
• Minimum: 3 years of demonstrated experience work in a medical device or pharmaceutical manufacturing environment.
• Experience with ISO13485 or 9001
• A thorough working knowledge of quality systems such as ISO 13485. 21 CFR Part 820 and/or Knowledge of 21 CFR Part 210 / 211 would be considered an advantage.
• Must be proficient with computers and various software programs such as Microsoft Word, Microsoft Excel, Microsoft Access, Microsoft PowerPoint.
• Experience with Master Control and SAP would be considered an advantage.

Benefits

• Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.
• We believe in giving back to help those in need in the communities where we live and work.
• Committed to creating a healthier environment and planet through our sustainability efforts.