Senior Quality Control Inspector

Job Description

Job Description

We're looking for an experienced Senior Quality Control Inspector to join an innovative medical device manufacturer that's changing lives through cutting-edge heart valve technology. If you're passionate about quality, have an eye for detail, and enjoy working in a highly regulated environment, this is an incredible opportunity to grow your career with an industry leader.

***Important: Training will take place on 1st Shift, then you'll transition to your regular 2nd Shift schedule.

As a Senior Quality Control Inspector, you'll play a critical role in ensuring every product meets the highest standards of quality before reaching patients. Your responsibilities will include:

• Performing functional, visual, final, and packaging inspections on medical devices.
• Reviewing production documentation and Device History Records (DHRs) for accuracy and compliance.
• Supporting product release activities to ensure products meet all quality requirements.
• Identifying and documenting quality issues, discrepancies, or nonconforming materials.
• Partnering with Manufacturing, Engineering, and Quality teams to resolve quality concerns.
• Supporting Material Review Board (MRB) activities.
• Assisting with inspections for Engineering, R&D, validations, and special projects.
• Training and mentoring Quality Inspectors on inspection techniques and procedures.
• Ensuring compliance with FDA, ISO 13485, GMP, GDP, and Quality System requirements.
• Verifying inspection equipment is calibrated and ready for use.
• Serving as a technical resource for inspection processes and quality standards.

Requirements:

• 3+ years of Quality experience within the medical device industry.
• Experience performing product inspections and final product release.
• Knowledge of: FDA 21 CFR Part 820, ISO 13485, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP).
• Strong documentation and organizational skills.
• Excellent attention to detail and problem-solving abilities.
• Comfortable working independently while collaborating with cross-functional teams.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint).