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Manufacturing Quality Assurance Specialist
1 month ago
We are seeking a highly skilled Manufacturing Quality Engineer to join our team at Katalyst Healthcares and Life Sciences. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality in our manufacturing processes.
Key Responsibilities- Oversee the implementation of Corrective Action Preventive Action (CAPA) processes to ensure compliance with regulatory requirements.
- Collaborate with cross-functional teams, including Manufacturing, Operations, and Engineering, to identify and resolve quality issues.
- Conduct effectivity checks for CAPAs and track RMA data for Management Review.
- Support RMA requests from customers and provide feedback to the customer.
- Monitor and measure Key Performance Indicators (KPIs) and present findings during Management Review.
- Conduct training on internal procedures and ensure compliance with regulatory requirements.
- Manage the Material Review Board (MRB) process and track nonconformance and MRB data.
- Represent Quality in product development teams and projects.
- Develop and execute quality plans, risk management, and Process Failure Mode and Effects Analysis (PFMEA).
- Lead Supplier Corrective Actions Requests (SCARs) and interpret Geometric Dimensioning and Tolerancing (GD&T).
- Bachelor's degree in an Engineering discipline.
- Knowledge of ISO 9001, ISO 13485, and other recognized international quality system standards.
- Excellent communication and problem-solving skills.
- Ability to work in a fast-paced environment and prioritize multiple tasks.
- Experience with Epicor and Microsoft Office Suite is a plus.
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual who is passionate about quality and manufacturing, we encourage you to apply for this exciting opportunity.
