Senior Quality Engineer - Medical Devices
- Flowery Branch, GA
- Permanent
- Full-time
- Provide Quality oversight to ensure quality processes are in place for the qualification of lab equipment and fixtures prior to use for GxP activity
- Responsible to ensure device testing, method development, method transfers and troubleshooting and all related documentation is compliant to applicable regulations
- Identify and control Manufacturing process defects (scrap, nonconforming material, custom complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions
- Support plans for development, verification/validation, technology transfer and risk management in line with applicable regulations for medical device products
- Provide Quality oversight for the development, review, and approval of key Design History File deliverables including Verification and Validation Protocols and Reports, Risk Management deliverables, and Transfer Plans
- Support root cause investigations, provide compliant options for resolving lab technical and quality issues (lab investigation reports), in compliance with QMS and regulatory expectations
- Draft, reviews, and approves Quality Agreements (QAG) for equipment vendor, method developers, and service providers
- Successfully accomplished Bachelor of Science degree in an engineering field
- long-term validation experience in a regulated manufacturing environment (FDA, EU) related to quality control of medical devices per ISO 13485 and 21 CFR 820
- Mastery of SOPs and other compliance requirements and regulatory guidelines as well as good documentation practices and cGMP standards
- Experience working in a clean room environment and performing process and equipment validations
- Thorough understanding of ISO 14971 from implementation through device lifecycle
- Experience with injection molding processes, parameters, and troubleshooting is preferred
- Fluent English communication skills, both oral and written, as required to communicate effectively with others at all levels in the organization
- Up to three (3) weeks of paid time off beginning your first year
- Twelve (12) company paid holidays per year
- Medical, dental, vision, Life/AD&D, Short- and Long-Term Disability, Identity Theft and Legal Protection plan options
- medmix Employee Savings Plan / 401k with 100% employer match up to 6% of your annual base salary
- Eligible to receive additional non-elective 401k contributions on a quarterly basis
- Health Savings Account with dollar-for-dollar matching based on coverage level
- Flexible working hours
- Employee Assistance, Health and Wellness Program
- An innovative, vibrant and agile culture
- Growth opportunities in a globally successful and dynamic business on a growth trajectory
- Access to a wide range of discounts on shopping, entertainment and lifestyle