Quality Associate III
Quality Associate III
Posted on :
27-06-2025
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1 Vacancy
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Job Description
Job description:
- The Quality Associate III plays a key role in ensuring supplier quality compliance and performance across the supply chain.
- The position supports both sustaining and new product initiatives by collaborating with internal teams and suppliers to establish robust quality systems process controls and continuous improvement strategies.
- The role operates within a regulated FDA environment requiring strong technical analytical and communication skills.
- Drive overall supplier quality performance including audits validations and corrective actions.
- Set expectations for supplier quality process control and continuous improvement.
- Participate in new product development teams to ensure quality integration.
- Conduct and coordinate supplier surveys quality system audits and process assessments.
- Collaborate with purchasing to monitor supplier metrics and support improvement plans.
- Work directly with suppliers to establish and maintain effective quality systems and root cause methodologies.
- Lead investigations related to non-conforming materials or components and perform CAPA.
- Validate supplier processes and components as needed.
- Support compliance through internal and supplier audits.
- Perform additional duties as assigned.
- Bachelors degree required.
- 3 5 years in Quality or a related field preferably in medical products or an FDA-regulated industry.
- ISO Led Auditor training preferred; CQE CQA or CSSBB desired
- Proficient in reading technical drawings/blueprints.
- Knowledge of FDA cGMP QSR ISO 13485 CMDAS ANSI/ISO/ASQC standards.
- Hands-on experience with metrology inspection and analytical techniques.
- Proficient in MS Office Suite Minitab Access and database systems.
- Strong problem-solving (CAPA) interpersonal and communication skills.
- Ability to manage multiple tasks and work independently or in cross-functional teams.
- Capable of influencing management with minimal supervision.
- Ability to travel as needed.
- Physically able to stand/walk for long periods and lift up to 20 lbs.
Employment Type
Full Time
Key Skills
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