Onsite Job Opportunity: Hiring QA Specialist in Medical Device Industry – Providence, RI
# **Hiring: QA Specialist – Medical Device Industry**
## **Exciting Opportunity for a Quality Assurance Specialist in the Medical Device Industry**
Are you an experienced **Quality Assurance (QA) Specialist** looking for a rewarding opportunity in a **regulated industry**? Do you have expertise in **Good Manufacturing Practices (GMP), FDA compliance, and ISO 13485 regulations**? If so, we have an exciting position for you!
We are actively seeking a **Quality Assurance Specialist** with **2-3 years of experience** in a **regulated industry**, preferably in **medical device manufacturing**. This **onsite position** is based in **Providence, RI**, and is a **12+ month contract** with a strong potential for extension. If you have a keen eye for detail and a passion for maintaining the highest **quality standards**, we encourage you to apply today.
## **Job Overview**
As a **QA Specialist** in the **medical device industry**, you will play a crucial role in ensuring that products meet stringent **regulatory and quality standards**. Your responsibilities will encompass **compliance oversight, document control, incoming material inspections, and quality system adherence** in accordance with **ISO 13485** and **FDA 21 CFR Part 820**. This is a high-impact role where you will collaborate with cross-functional teams to drive quality excellence.
## **Key Responsibilities**
### **1. GMP Compliance and Quality System Oversight**
– Ensure adherence to **Good Manufacturing Practices (GMP)** in all production processes.
– Maintain compliance with **FDA 21 CFR Part 820** and **ISO 13485**.
– Assist in internal and external audits to uphold quality and regulatory standards.
– Implement **corrective and preventive actions (CAPA)** to address quality concerns.
### **2. Document Control and Quality Assurance**
– Manage and maintain **quality documentation**, ensuring accuracy and completeness.
– Review and approve **Standard Operating Procedures (SOPs)**, work instructions, and validation protocols.
– Ensure documentation is in compliance with **industry regulations**.
– Assist in training staff on quality procedures and document control requirements.
### **3. Incoming Material Inspections**
– Conduct thorough **inspections of raw materials and incoming components**.
– Work with suppliers to ensure **materials meet quality specifications**.
– Investigate **non-conforming materials** and initiate appropriate action.
### **4. Continuous Improvement Initiatives**
– Support continuous improvement efforts within the **quality management system (QMS)**.
– Identify process gaps and recommend improvements to enhance efficiency.
– Participate in **risk management and failure analysis** activities.
## **Qualifications and Requirements**
To excel in this role, candidates should meet the following criteria:
– **Bachelor’s degree in a scientific or engineering discipline** (or equivalent experience).
– **2-3 years of quality assurance experience** in a **regulated industry**, preferably **medical devices**.
– Strong understanding of **ISO 13485, FDA 21 CFR Part 820, and GMP guidelines**.
– Experience with **document control, CAPA, and quality audits**.
– Detail-oriented with excellent problem-solving and analytical skills.
– Ability to **collaborate cross-functionally** with engineering, production, and regulatory teams.
– Strong written and verbal communication skills.
– Proficiency in **Microsoft Office Suite** and quality management systems (QMS software preferred).
## **Why Join Our Team?**
– **Competitive Compensation** – We offer a **competitive salary** and benefits package.
– **Career Growth** – Gain valuable **experience in medical device manufacturing** and **regulatory compliance**.
– **Dynamic Work Environment** – Work with a passionate team dedicated to **excellence in quality assurance**.
– **Long-Term Opportunity** – This is a **12+ month contract** with a potential extension based on performance.
– **Providence, RI Location** – Join a thriving medical device industry hub with excellent career opportunities.
## **How to Apply**
If you are ready to take the next step in your **Quality Assurance career**, we would love to hear from you. **Contact us today** to learn more about this exciting opportunity!
📱 **Mobile**: [503-863-0534](tel:503-863-0534)
📧 **Email**: [[email protected]](mailto:[email protected])
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