Senior Quality Assurance Specialist
3 weeks ago
Job Title: Senior Quality Assurance Specialist
We are seeking a skilled Senior Quality Assurance Specialist to independently establish quality standards for in-process and finished products at Medix™. This role focuses on developing and implementing testing, sampling, and training methods, while also supporting process improvements and vendor management.
Key Responsibilities:
- Develop and implement methods for process control, validation, improvement, testing, and inspection to ensure product quality and functionality.
- Design and conduct experiments to analyze sources of variation in products and processes, applying statistical process control (SPC) for evaluation.
- Conduct product testing and analysis to maintain quality, minimize defects, and lead corrective actions through data-driven decisions using probability and statistical methods.
- Collaborate with suppliers to resolve quality issues, lead corrective and preventive actions (CAPA, SCAR), and drive supplier quality improvement programs, including supplier qualifications.
- Provide expertise in Product Development, Design Control, Risk Management, and CE Technical Files.
- Ensure compliance with domestic and international regulations, contributing to the creation of 510K submissions and other regulatory documentation.
- Coordinate internal and external product testing, and ensure adherence to applicable standards (21 CFR 820, ISO 13485, etc.).
- Lead investigations into non-conformance and out-of-specification results, developing effective CAPAs.
- Support team members and employees through training and best practices, acting as the Quality lead in the absence of management.
Qualifications:
- Bachelor's degree in Engineering, Science, Math, or a related technical field.
- Minimum of 4 years of experience in Quality or Engineering.
- Experience with industry standards (e.g., 21 CFR 820, ISO 13485, MDD/MDR) and applying quality assurance codes.
- Proficiency in managing complex projects independently, with strong time management and problem-solving skills.
- Proven experience in leading cross-functional teams.
- Advanced proficiency in Microsoft Excel (pivot tables, reporting, formulas, etc.) and familiarity with MS Office Suite.
- Willingness to travel up to 15%.
Preferred Qualifications:
- 5+ years of experience in Medical Devices, Pharmaceuticals, or a related field.
- Knowledge of Six Sigma/Lean concepts.
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