Quality Engineer at medmix

Flowery Branch, Georgia, United States -

Full Time

Start Date

Immediate

Expiry Date

12 Jul, 26

Salary

0.0

Posted On

14 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality management systems, Regulatory compliance, ISO standards, FDA regulations, GMP, Root-cause analysis, CAPA, PFMEA, Nonconformance reporting, Injection molding, Technical documentation, Risk assessment, Internal auditing, Data analysis, Process improvement, Troubleshooting

Industry

Medical Device

Description

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 Job Description Our manufacturing site in Flowery Branch Georgia is actively searching a Quality Engineer. This position will be responsible for assisting with the implementation, management, and administration of the quality management system and ensuring products are manufactured per quality and regulatory requirements and industry best practices. Main accountabilities and tasks Assist in monitoring the Quality System, including review of records and process results, to ensure product quality and regulatory compliance. Support continuous improvement efforts within the Quality System. Maintain knowledge of current regulatory requirements for medical device manufacturing and combination product manufacturing and communicate key requirements to staff. Ensure manufacturing and quality documentation is accurate, controlled, and compliant with GMP, internal procedures, and regulatory standards. Conduct weekly quality walk‑throughs to assess compliance and identify improvement opportunities. Ensure compliance with OSHA and other applicable health and safety regulations. Conduct internal audits in accordance with current ISO standards and FDA regulations. Administer and maintain the ISO Quality System, including certification renewals, quality manuals, quality records, process maps, and work instructions. Understand and apply relevant FDA regulations (e.g., 21 CFR Part 4). Maintain and apply knowledge of company policies, regulations, and industrial processes Maintain quality records procedures and support the nonconformance reporting process. Review and approve nonconformance reports; coordinate cross‑department follow‑up; calculate cost of quality; and identify trends or significant issues for management escalation. Lead investigations of quality issues as required, using structured root‑cause analysis techniques. Provide analysis and trending data to support issue investigations and CAPA activities. Collaborate cross‑functionally to address containment actions and implement corrective actions. Conduct risk assessments using tools such as PFMEA. Assist in setting standards for thorough and timely QA documentation review. Provide constructive feedback to QA and Operations personnel regarding documentation quality. Write and revise quality manuals, procedures, policies, and related work instructions. Participate in continuous improvement initiatives to maintain regulatory compliance and improve operational quality. Recommend enhancements to improve quality performance and operational efficiency. Perform other duties and additional projects as assigned by management. Qualifications Work Experience: 1-3 years of experience manufacturing in a quality environment. Education: Bachelor’s degree in Industrial Engineering and or Technology/Engineering Other: Experience with injection molding processes, parameters, and troubleshooting is preferred Knowledge of ISO standards is a must 1-3 years of experience using quality management tools. Proficiency in the use of personal computers, especially word processing software, spreadsheets, presentation, and database software. Ability to learn quickly and maintain the Quality Assurance metrics. Knowledge of ISO standards or the ability to quickly learn and retain knowledge as required for system compliance. Ability to perform work accurately and thoroughly and to work independently with minimal supervision. Must be organized and have the ability to follow a systematic and/or documented method of performing tasks and the ability to organize and direct a project to completion. Ensures manufacturing and quality documentation is accurate, maintained, and reflects GMP, procedural and regulatory requirements. Must be self-directed and motivated to optimally utilize the available time to organize and complete expected work within given deadlines and reasonable work schedules. Communication skills, both oral and written, as required to communicate effectively with others at all levels in the organization and to provide clear and concise reports and policies as needed. Ability to effectively present information publicly. Ability to work well with subordinates, peers and superiors in all departments. Ability to work onsite full 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 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 Employee Assistance, Health and Wellness Program Flexible working hours and hybrid on-site/home office model Access to a wide range of discounts on shopping, entertainment and lifestyle medmix is an equal opportunity employer, committed to the strength of a diverse workforce. 93% of our employees would go above and beyond to deliver results – do you have the drive to succeed? Join us and boost your career, starting today! All information will be kept confidential according to EEO guidelines. Business Segment: Operations Location: Atlanta - Flowery Branch

Responsibilities

The Quality Engineer will assist in the implementation and management of the quality management system to ensure regulatory compliance and product quality. They will lead investigations into quality issues, conduct internal audits, and collaborate cross-functionally to implement corrective actions.