Job Description
We are seeking a skilled Quality Engineer to independently establish quality standards for in-process and finished products. This role focuses on developing and implementing testing, sampling, and training methods, while also supporting process improvements and vendor management. You will be responsible for maintaining product documentation, ensuring compliance with regulatory requirements, and leading quality initiatives.
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.
