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Quality Assurance Technician
2 months ago
Job Title: Quality Assurance Technician
Reports To: Quality Manager
Position Location: Buffalo, NY
FLSA Status: Non-Exempt
Position Summary:
As a Quality Assurance Technician at Cole-Parmer Instrument Company, you will play a critical role in ensuring the quality of our products and services. Your primary responsibility will be to develop, implement, and maintain quality systems and processes that meet regulatory requirements and company standards.
Key Responsibilities:
- Perform Final QC Checks: Conduct thorough inspections of outgoing product shipments to ensure accuracy and compliance with written specifications.
- Release of Incoming Materials: Verify and release incoming materials, manufactured materials, and finished products according to written specifications.
- Equipment Qualification and Calibration: Assist in the maintenance of the equipment qualification and calibration program, including upkeep of the equipment database.
- Document Control and Training: Perform document control and training activities as assigned, including the development and implementation of company SOPs.
- Regulatory Compliance: Ensure compliance with relevant FDA, ISO 13485, and EU regulations by participating in audit responses, deviation, nonconformance, complaint, and CAPA processes as necessary.
- Communication and Collaboration: Promote and participate in training activities related to the quality management system and product quality, safety, and efficacy.
Requirements:
- Education: Associate's Degree in a related field or equivalent work experience.
- Experience: 1 or more years of previous related experience.
- Skills: Good communication and organizational skills, ability to multitask, and prior experience with ISO 13485 and 21 CFR 820.
Physical Requirements/Working Conditions:
- Exposure to Hazardous Chemicals: Control exposure to carcinogens, strong and obnoxious fumes, sharp and dangerous blades and needles, and biohazard exposure to specimens.
Salary Range: $37,000 - $52,000, depending on location and experience.
Relocation Assistance: This position has not been approved for relocation assistance.
Equal Employment Opportunity: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.