At-a-Glance:
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring a Quality Engineer.
Position Type:
Required:
- Bachelor’s degree in a technical/scientific discipline; Master’s or PhD experience beneficial.
- 2-5 years of experience in Quality Systems within regulated industries, preferably medical devices.
- Knowledge of GMP, GLP, ISO, Six Sigma, Root Cause Analysis, and statistical analysis
- Strong understanding of microbiology, molecular biology, biochemistry, chemistry, and related laboratory/manufacturing sciences.
- Proven ability to plan, execute, and supervise projects, including risk assessment, CAPAs, and technical investigations.
- Excellent technical writing, analytical, and problem-solving skills, with experience documenting investigations, reports, and process improvements.
- Ability to work in controlled environments, clean rooms, high-voltage electronics, and radiation areas, while collaborating effectively across teams.
Responsibilities:
- Design, implement, and maintain quality assurance protocols for materials, partially finished, and finished products.
- Lead and execute moderate to complex projects, including Change Orders (ECOs), CAPAs, Non-Conformance Events (NCE), and product/process investigations.
- Write, execute, and coach others on PQs, TMVs, and simple procedure updates, ensuring team adherence to quality standards.
- Perform risk management, defect investigations, and root cause analyses, providing sustainable corrective actions and preventive measures.
- Collaborate with Operations, Engineering, and R&D to ensure regulatory and quality compliance across all processes, products, and documentation.
- Author and review technical protocols, reports, and quality documentation, maintaining compliance with QMS, FDA, ISO, and Medical Device Directive requirements.
- Analyze production data and large datasets, identify trends, recommend process improvements, and mentor junior engineering staff in quality best practices.
Get in Touch:
We want to hear from you! If you think you'd be a good match, submit your resume and reach out to Vaibhav at 551-227-9117 to learn more.
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