Senior Quality Engineer Combination Product
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Job Location:
Flowery Branch, GA - USA
Monthly Salary:
Not Disclosed
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
- Provide Quality Engineering support for combination products molding assembly and automated manufacturing lines and medical device operations.
- Ensure compliance with FDA 21 CFR Part 820 21 CFR Part 4 ISO 13485 ISO 14971 and applicable global regulatory requirements.
- Participate in or lead risk management activities per ISO 14971 including DFMEA PFMEA hazard analyses and control strategy development.
- Own and maintain Quality System documentation including work instructions specifications and control plans.
- Lead or support investigations for nonconformances deviations and customer complaints through root cause analysis using tools such as 5 Whys Fishbone Fault Tree Analysis or DOE.
- Develop and implement effective Corrective and Preventive Actions (CAPA); verify and validate effectiveness.
- Monitor manufacturing risks and develop mitigation strategies focused on patient safety and product quality.
- Lead compliance efforts for handling scheduled drug products.
- Assist in training compliance DEA requirements
Qualifications :
- Technical Knowledge: Proficiency in AutoCAD/SolidWorks GD&T (Geometric Dimensioning and Tolerancing) and statistical software.
- Methodologies: Strong experience with Lean manufacturing Six Sigma and DMAIC (Define Measure Analyze Improve Control).
- Analytical Skills: Ability to interpret data charts and reports to drive improvements.
- Education/Experience: Usually requires a bachelors degree in engineering (Mechanical Industrial Chemical) and 5 years of experience in regulated environments.
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
Key Skills
- Quality Assurance
- Six Sigma
- Design Controls
- FDA Regulations
- ISO 9001
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
About Company
medmix es líder mundial en dispositivos de administración de alta precisión, con posiciones de liderazgo en los mercados finales de la sanidad, consumo y la industria.Nuestros clientes se benefician de nuestra orientación a la innovación y al avance tecnológico, que se ha traducido en ... View more
