- Work on a wide variety of products in the medical device industry end-to-end
- Work with management to grow this team and help guide your upward potential
About Our Client
Our client is an ISO 13485 certified medical device component manufacturer that provides end-to-end solutions for their clients. They take their customer's specifications and run them from initial design stages through packaging. Through attention to detail and a dedicated team, our client is one of the most trusted medical device manufacturers for big name distributors.
Essential duties and responsibilities for the Sr. Quality Engineer:
- Plan, coordinate, and direct the application of Quality Engineering practices for New Product Development and Design Transfer teams on a project basis from concept to commercialization.
- Manage all quality aspects of the design control process including quality planning, verification and validation planning and execution, risk management.
- Manage the quality of technical team's implementation of incoming inspection, calibration, and inventory control systems. Plan, promote, and organize training activities related to quality system improvements.
- Review and approve Engineering Change Orders and support the material review board processes as needed
- Develop and qualify incoming, in-process and final inspection methods using standard techniques such as Gage R&R. Analyze data for NPD and Design Transfer teams and participate in failure analysis including the application of Root Cause Analysis techniques.
- Implement company quality policies and procedures of the Quality Management System and ensure compliance with US - CFR 21 part 820 (FDA QSR, GMP), ISO 13485 - (EN) ISO 13485 and ISO 14971.
- Up to 20% of travel
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 Successful Applicant
Qualifications for the Sr. Quality Engineer:
- Bachelor's degree in Engineering with 5 years of progressive medical device engineering experience in Design Controls, Development and Quality Engineering or Advanced degree in Engineering with 2 years of progressive medical device engineering experience in Design Controls, Development and Quality Engineering
- Experience applying quality regulations and standards (e.g. US - CFR 21 part 820, GMP, ISO 13485 - (EN) ISO 13485, ISO 14971).
- Applied experience in design controls, risk management, verification and validation, test method validation, statistical methods and sampling plans.
- Practical experience with SPC, GD&T and mechanical drawings.
- Experience working with plastic injection molding and electromechanical medical devices.
- Computer systems for the analysis of data, specifically Minitab or equivalent statistical packages.
What's on Offer
Our client is offering the Sr Quality Engineer:
- Competitive Salary and Bonus Potential
- Upwards Mobility
- Comprehensive Medical Plan Options
- Vision/Dental Plan
- 401(k) Savings Plan
- Life Insurance Plan
- Vacation and Holiday Pay