Healthcare Quality Systems Engineer

• Assist with the process of monitoring the quality system including records and results from processes and procedures to ensure product Quality and compliance
• Support improvement efforts within the Quality system
• Assist with setting the standard for QA documentation review regarding quality review thoroughness and timeliness
• Ensure manufacturing and quality documentation is accurate maintained and reflects GMP procedural and regulatory requirements. Provide constructive feedback to QA and Operations staff regarding documentation quality
• Maintain knowledge of current regulatory requirements pertaining to medical device manufacturing and communicates requirements to other associate staff
• Conduct weekly walk-throughs to ensure quality compliance and internal audits to comply with the current ISO standards
• Ensure compliance to legal and company requirements with OSHA and other health and safety regulations as well as continuous improvement of compliance regulations
• Lead investigations of quality issues as required. Provide analysis and trend information to support these activities
• Responsible for administration of and compliance with the ISO quality system and for administration as required to maintain and renew the certification upon expiration; for coordinating revisions to or required upgrades for the quality system; and for maintaining required Quality Manual all quality records process maps and work instructions for the location in Oakwood GA
• Maintain quality records procedure and coordinate non-conformance reporting
• Review and approve non-conformance reports calculate related cost of quality coordinate cross-department issues and notify management team of trends or significant issues
• Assist with writing and revising quality manual regulations policies and related work instructions
• Compile analyze and interpret statistical data related to quality operations
• Responsible for monitoring outside vendors to insure they are following medmix quality processes

Qualifications :

• Bachelors degree in Industrial Engineering or a related field
• First experience in a quality unit within a manufacturing environment of the healthcare / medical devices industry
• Experience using quality management tools and QMS
• Knowledge of ISO standards and understanding of FDA regulations i.e. 21 CFR Part 4
• Experience with injection molding processes parameters and troubleshooting is preferred
• Ability to organize priorities and deadline self-directed
• Experience communicating across different levels in the organization and provide clear and concise reports and policies
• You will need to work onsite on a daily bases / 100% of your work time

Additional Information :

Benefits we offer:

• An innovative vibrant and agile culture 
• Growth opportunities in a globally successful and dynamic business on a growth trajectory
• Excellent employee benefits including:
  • Medical dental vision Life/AD&D Short- and Long-Term Disability
  • Employee Savings Plan / 401k with 100% employer match

Remote Work :

No

Employment Type :

Full-time