As a Quality Engineer for a manufacturer of medical devices, you will play a key role in ensuring the compliance, reliability, and performance of products.
Key Responsibilities
- Quality Systems Management
- Conduct internal audits to ensure adherence to quality procedures
- Develop and validate manufacturing processes
- Working knowledge of PPAP activities (correlation studies, GR&R, Capability, etc…)
- Complaint handling to investigate and resolve quality issues, implementing root cause analysis and corrective/preventive actions (CAPA).
- Collaborate with regulatory teams to ensure product compliance with applicable FDA and international medical device regulations.
- Evaluate and qualify suppliers
- Interface with customers to address quality-related issues
- Prepare and maintain quality documentation, including standard operating procedures (SOPs), work instructions, and inspection records.
- Analyze quality data, generate reports, and recommend improvements
- Train and mentor staff on quality standards and best practices.
- Bachelor’s degree in Engineering, Quality Management, or or equivalent experience.
- 2+ years of experience in quality engineering within the medical device industry.
- Hands-on experience with ISO 13485 QMS and FDA regulations (21 CFR Part 820).
- Experience with risk management and statistical process control (SPC).
- Proficiency in quality tools such as FMEA, Root Cause Analysis, and Six Sigma methodologies.