What are the responsibilities and job description for the Quality Assurance Associate position at Dukal Corporation?
JOB OVERVIEW:
The Quality Assurance Associate will play a pivotal role in overseeing complaint records, ensuring meticulous document control, supporting audits and inspections, and maintaining strict compliance with regulatory standards. This position requires collaboration with various departments to address quality-related issues and drive process improvement initiatives. Additionally, the Quality Assurance Associate will be responsible for maintaining Safety Data Sheets (SDS), managing change requests, and ensuring adherence to CTPAT requirements.
Key Responsibilities
- Review and process assigned complaint records related to product quality and patient safety.
- Gather, compile, and analyze complaint trend data and escalate issues related to customer complaint trends and non-conforming products.
- Participate in complaint review board meetings.
- Collaborate with internal and external resources to research and validate defects and identify root causes.
- Document investigations including research, analysis, findings, and status updates in Quality systems.
- Ensures complaint files are investigated, completed and closed in a timely manner
- Interact with customers verbally or in writing using clear, effective communication. This may involve translating technical language into more common terms easily understood by customers.
- Maintain up-to-date records for quality-related documents, including supplier qualification records.
- Facilitate and manage the product testing program ensuring compliance with regulatory standards and company specifications
- Help track employee training records, ensuring all relevant personnel are trained in department specific procedures.
- Participate in special projects and perform other duties as needed.
Specific Knowledge & Skills
- Basic knowledge with quality management systems, regulatory requirements, and industry standards (ISO 13485, MDSAP, 21 CGR 820, 210, and 211)
MINIMUM WORK EXPERIENCE:
- Typically, 1 or more years of related experience.
Preferred Education
- This position requires general education, vocational training, or on-the-job training. Bachelor’s degree in a related field preferred.
Travel/Physical Demands
- Travel typically less than 10%. Hybrid office environment. No special physical demands are required.
The posted range for this position is $43,268 – $59,494 which is the expected starting base salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay within the posted range including education, prior experience, training, current skills, certifications, location/labor market, internal equity, etc.
Salary : $43,268 - $59,494
