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Manufacturing Line Quality Assurance Specialist
2 months ago
About the Role:
Spectraforce Technologies Inc is seeking a skilled Manufacturing Line Quality Assurance Specialist to join our team in the Infectious Disease Developed Markets business unit. As a key member of our quality assurance team, you will play a critical role in ensuring the highest quality standards are met in our manufacturing processes.
Key Responsibilities:
- Quality Issue Resolution: Collaborate with production teams to resolve quality issues in accordance with established procedures, ensuring timely and effective resolution to minimize downtime and optimize productivity.
- Manufacturing Floor Support: Provide support on the manufacturing floor, ensuring adherence to procedures and maintaining accurate device history records (DHRs). Participate in line clearances, reworks, and inspections as required.
- Quality Management System: Demonstrate commitment to the development, implementation, and effectiveness of our Quality Management System, aligning with ISO, FDA, and other regulatory agency requirements.
- Professional Behavior: Exhibit professional behavior with internal and external business associates, reflecting positively on the company and upholding our policies and practices.
- Quality Consequences: Understand and be aware of the quality consequences that may occur from improper performance, including device defects in product design, verification, validation, manufacturing, and testing activities.
- Additional Responsibilities: Perform other duties as assigned, adapting to the changing needs of the business.
Requirements:
- Education: Bachelor's Degree in Engineering, Chemistry, Biotechnology, Life Science, or a related technical field, or an equivalent combination of education and experience.
Preferred Qualifications:
Competencies:
- Technical Skills: Working knowledge of database software, internet software, inventory software, spreadsheet software, and word processing software.
- Regulatory Knowledge: Familiarity with FDA, cGMPs/QSR, and ISO quality system requirements.
- Communication Skills: Strong technical writing skills and effective communication skills.
