Quality Engineer, Medical Devices
Assist in ISO 13485 Certification Audit
Site Quality Engineer role with medical device provider
About Our Client
Our latest client is an FDA-approved OEM medical device company with significant operations across the globe.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
- Provide Quality Assurance support and guidance for incoming inspection, in-process inspection and final inspection activities
- Review and investigate customer complaints daily, makes an initial reporting decision, and ensures completeness and consistency of complaint and related documentation
- Leads Corrective and Preventive Actions (CAPA) and nonconformances through root cause analysis, identification of solutions and implementation
- Use statistical trending tools to monitor product complaint trends
- Perform First Article inspections and incoming material inspections
- Interacts with suppliers, third party customers, and outside testing laboratories and provides Quality Assurance assistance where needed on specific issues
- Assist as needed with the Internal Audit Program
- Performs other duties as assigned
The Successful Applicant
- Bachelor of Science degree in engineering (I.e. Mechanical, Electrical, Biomedical, Plastics, or Chemical)
- 3+ years of full-time Quality Management experience in the medical device industry.
- Six Sigma Green or Black Belt Strongly Preferred
- Experience in medical device design and manufacturing of capital equipment and sterile disposable medical devices is strongly preferred
- Thorough knowledge and understanding of FDA QSR, ISO 13485 regulations
What's on Offer
- Competitive base salary between $65,000-$$80,000, depending on project experience and skills
- Growth company- this organization is expecting to double its size over the next few years
- Great benefits package - annual bonus, matching 401k, medical, dental, life.
- Comprehensive benefits package (100% Coverage for Individual & Dependents)