Quality Engineer - Medical Device Experience
Ability to work for a well-respected, established medical device manufacturer!
Strong culture, excellent management team!
About Our Client
Our client is an HME distributor and manufacturer that has been in business for over 15 years. They have a national presence, and manufacture high-quality, affordable products. They are looking for a talented Quality Engineer to add to their growing team.
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.
The Quality Engineer will be responsible for the following;
Ensure compliance with global quality systems and regulatory requirements related to product investigations, nonconformances, and CAPAs
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
The Successful Applicant
- Bachelor of Science degree in engineering (I.e. Mechanical, Electrical, Biomedical, Plastics, or Chemical)
- Ideally 3+ years of full-time Quality Management experience in the medical device industry
- Experience with QMS, specifically ISO 13485
- 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 $60,000-$75,000, depending on experience and skills
- Great benefits package - annual bonus, matching 401k, medical, dental, life.
- Comprehensive benefits package (Coverage for Individual & Dependents)
- 15 PTO Days