Senior Quality Assurance Specialist
hace 6 días
Job Title: Senior Quality Assurance Specialist - Medical Device Manufacturing
Company Overview:CooperCompanies is a leading medical device manufacturer dedicated to delivering high-quality products and services to patients worldwide.
Estimated Salary:$110,000 per year
Job Description:The Quality Engineer II will play a critical role in ensuring the quality of our medical devices, from design to delivery. As a key member of our Quality team, you will be responsible for providing quality assurance knowledge and hands-on support for all aspects of production operations, quality control activities, and transfer of new product launches.
Key Responsibilities:
- Ensure compliance with FDA regulations, ISO standards, customer requirements, and internal policies and procedures.
- Represent Quality in signing on Change Orders.
- Manage all Quality responsibilities for assigned manufacturing changes and transfer of new product launches.
- Perform process improvements to increase quality compliance.
- Participate in validation activities, including qualification/validation of production processes.
- Investigate customer complaints, including root-cause analysis, and develop corrective action plans.
- Ensure disposition of non-conforming materials meets regulatory requirements.
Requirements:
- Bachelor's degree in engineering required.
- Experience in medical device manufacturing.
- 3+ years of work experience in Quality Engineering role or equivalent.
- Working knowledge of regulated environments (ISO 13485, 21 CFR 820).
- Root Cause Analysis (CAPA/NCR) experience as owner.
- Experience in planning Process Validation, IQ/OQ/PQ/MSA.
We are an equal opportunities employer and welcome applications from diverse candidates. Our company policy prohibits harassment of employees or applicants based on characteristics such as race, color, religion, sex, sexual orientation, gender identity or expression, age, national origin, disability, genetic characteristic, or other protected characteristics.
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