What are the responsibilities and job description for the ISO Quality Specialist position at Astrix Technology Group?
Responsibilities
- Develop, implement, and maintain an ISO 9001:2015 quality management system / program for all non-GMP products that conforms to customer, internal, ISO 9001 and regulatory/legal requirements
- Develop and perform relevant training in support of the Quality Management System
- Lead and manage the customer complaints process including investigation and resolution
- Lead ISO internal audits and related activities
- Manage corrective action and preventive action (CAPA) program for non-GMP products
- Act as company point of contact during customer inquiries, including customer audits and questionnaires
- Monitor/measure processes for the detection of continuous improvement opportunities
- Establish and maintain statistical quality control (SQC) program in coordination with the Quality Control department
- Manage critical supplier assessment program
- Work with production and engineering to ensure processes meet quality expectations
Requirements
- Bachelor’s Degree in Sciences preferred
- A minimum of 5 years of experience in an ISO 9001-accredited environment
- Experience working with CAPA and internal audits
- Excellent interpersonal, verbal and written communication skills required
- Attention to detail, strong organizational skills, ability to multitask
- Work independently and in a team environment
- Able to travel occasionally
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