- Join an industry leader in the medical device space
- Report directly to the Director of Quality
About Our Client
Our client is a Medical Device Manufacturer that has grown rapidly over the last 5 years and continues to expand their product line. They focus on surgical technologies with customers like Smith & Nephew and Medtronic. They've recently introduced a proprietary product that will be sold directly to hospitals.
- 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 customer's defined critical features.
- Assist with Advance Product Quality Planning (APQP):
- Develop Quality Plans for new products
- Identify and maintain key characteristics of parts.
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
- Bachelor's degree required; STEM (Science, Technology, Engineering, or Mathematics) related field, equivalent experience, and ASQ certification accepted.
- IQ/OQ/PQ experience
- 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)
What's on Offer
- Competitive base salary, dependent on experience
- 15+ days of time off
- Medical, Dental, Vision insurance
- 401k Match of 4%
- Tuition reimbursement