What are the responsibilities and job description for the Senior Quality Control Inspector position at Innovative Career Resources & Staffing?
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).
Salary : $30