Quality Engineer- Medical Device

Work for an industry leader in the medical device space
Progression opportunities

About Our Client

Our client is an established Medical device manufacturer with clients like Stryker and Medtronic. They have steadily grown over the last 10 years and plan to open in a new facility in the next year. They seek an experienced Quality Engineer that has energy, passion and the ability to learn quickly. This role will report to their Senior Quality Manager and have a path for growth and promotion.

Job Description

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.

Description

Participate in Material Review Board (MRB) and Corrective and Preventive Action (CAPA) processing
Work closely with Sales, Customer Service, Production, Engineering, and R&D to resolve quality issues, improve product and process quality
Quality & Cost Improvement Projects: Design and implement methods for process control, process improvement, testing, and inspection.
Support Cost of Quality implementation, and drive improvement initiatives to reduce the overall cost of ownership.
Ensure the work in quality is completed according to expected delivery dates.
Establish / Implement / Maintain control plans that address all customers' defined critical features.
Assist with Advance Product Quality Planning (APQP):
Develop Quality Plans for new products
Identify and maintain key characteristics of parts.

The Successful Applicant

Bachelor's degree required; STEM (Science, Technology, Engineering, or Mathematics) related field, equivalent experience, and ASQ certification accepted.
Working Knowledge of the 21 CFR 820 QSR, ISO 13485:2016, ISO 9001:2015
Knowledge of engineering concepts as they relate to a manufacturing organization.
Intermediate SPC/Data analysis skills and proven ability to perform DOE, FMEA, ANOVA, and Gage R&R analysis
Experience using standard quality tools i.e. Flow Charts, Pareto Charts, Histogram, Control Charts, Ishikawa Diagram, 5 Why's
Ability to successfully use basic office software applications (specifically MS Excel, MS Word, and MS Outlook)