Healthcare Quality Systems Engineer

Company Description

medmix is a global leader in high-precision delivery devices. We occupy leading positions in the healthcare, consumer, and industrial end-markets. Our customers benefit from our dedication to innovation and technological advancement that has resulted in over 900 active patents. Our 14 production sites worldwide, together with our highly motivated and experienced team of nearly 2’600 employees provide our customers with uncompromising quality, proximity, and agility. medmix is headquartered in Baar, Switzerland. Our shares are traded on the SIX Swiss Exchange (SIX: MEDX). www.medmix.swiss

As Healthcare Quality Systems Engineer you will be responsible for assisting with the implementation, management, and administration of the quality management system and ensuring products are manufactured per quality, regulatory requirements and industry best practices. You will be part of a team of over ten quality experts at our Flowery Branch (Georgia - GA) facility.

Job Description

• 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

• Bachelor’s 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