Overview
Quality Assurance Specialist Jobs in Village of Skaneateles, New York, USA at Integration International Inc.
Location: Village of Skaneateles
Job Title:Quality Assurance Specialist
Location: Skaneateles, NY
Duration: 12 months contract
Pay rate: $32.78/hr on W2
Summary:
The Quality Complaint Investigation Specialist is responsible for investigating, reviewing, and analyzing quality complaints, identifying systemic issues, and driving corrective actions to improve product quality. This role ensures compliance with industry regulations and supports continuous improvement initiatives in the medical device manufacturing environment.
Key Responsibilities:
Review complaints and service data to assess risk and investigate root causes.
Analyze data from multiple sources (e.g., FCA, MDR) to identify trends and systemic issues.
Develop and implement strategies to close compliance gaps in investigations.
Lead corrective and preventive actions using problem-solving tools.
Support CAPA activities and process improvements for existing product lines.
Communicate quality performance expectations and support the development of quality systems.
Qualifications:
1-3 years of medical device experience.
Knowledge of FDA cGMP, 21
CFR
820, and quality system standards (e.g., ANSI/ISO).
Strong problem-solving skills and experience with statistical software (Minitab preferred).
Ability to analyze data, develop reports, and manage projects.
Physical Requirements:
Ability to lift up to 40 pounds.
Must be able to sit for extended periods and have good hand-eye coordination.
FDA-regulated manufacturing environment.
Must wear protective equipment (e.g., smocks, wrist straps) and work in a temperature-controlled space.
Seniority level: Associate
Employment type: Contract
Job function:Quality Assurance
Industries: Medical Equipment Manufacturing and Pharmaceutical Manufacturing
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Title: Quality Assurance Specialist
Company: Integration International Inc.
Location: Village of Skaneateles, New York, USA
Category: Quality Assurance – QA/QC, Healthcare
