- Excellent Company Culture
- Opportunity to join a growing organization
About Our Client
Our client is a global strategic manufacturing partner that helps medical device OEMs bring complex medical devices and components to market. A manufacturer for endoscopic, arthroscopic, and single biopsy devices partnering with customers like Stryker, Medtronic, and Smith & Nephew.
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.
Reporting directly to the Director of Quality, the Quality Engineer will be apart of a team of 3 to help drive quality control standards, external regulations, and improve customer projects. Specific responsibilities and duties include:
* Performs Internal Audits of the Quality Management System to ensure compliance to procedural, customer, and regulatory requirements
* ISO 13485
* Drive Corrective and Preventative Action plans (CAPAs) to improve or minimize customer quality open issues
* Develop root cause analysis methods and implement control plans for manufacturing teams
* Develops and analyzes statistical data and product specifications to determine present standards and establish proposed quality and reliability expectancy of finished product.
* Provides inspection activity for product throughout production cycle.
* Applies total quality management tools and approaches to analytical and reporting processes within each department.
* Directs workers engaged in inspection and testing activities to ensure continuous control over materials, facilities, and products.
* Works with suppliers to insure quality of all purchased parts for company use.
* Design and implement quality control training programs to key personnel in conjunction with managers.
* Investigates and adjusts customer complaints regarding quality.
The Successful Applicant
* Bachelors degree
* 3+ years of experience in quality and manufacturing in a regulated environment
* Medical Device (ISO 13485 and FDA) experience is a plus
* Knowledge of managing company QMS, SPC, GMP
* Possess strong written, oral, and mathematical skills
What's on Offer
* Offers a competitive bonus of 6%
* Benefits package includes: dental, vision, health, short and long term life
* 3 Weeks PTO, 5 Sick Days
* Progression to lead an entire manufacturing site