- Growing Medical Device Manufacturer
- Recently launched a new product
About Our Client
Our client is a Medical Device Manufacturer that focuses on surgical technologies with customers like Smith & Nephew and Medtronic. They have grown rapidly over the last 5 years and continue to expand their product line. They've recently introduced a proprietary product that will be sold directly to hospitals. They seek a motivated Quality Engineer that will report to their Director of Quality.
- Currently headcount is around 75, their strategic goals are to double both headcount and revenue in the next 3 years
- Establish activities for the development, application and maintenance of quality standards for processes, Supplier control, materials, and products
- Develop standards and methods for inspection, testing, and evaluation, utilizing knowledge in engineering fields such as chemical, electrical, or mechanical
- Develop sampling procedures, forms and instructions for recording, evaluating, and reporting quality and reliability data
- Develop methods and procedures for disposition of discrepant material and devise methods to assess cost and responsibility
- Organizes, writes and conducts training sessions on quality control activities.
- Plans all required test fixtures and tools for the correctness of components and products
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.
- 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, between $75,000 and $95,000
- Sign-on Bonus
- Medical, dental and vision insurance - Employer covers 90% of cost, through Blue Cross
- 15 days of Vacation
- 5 Sick Days
- 10 Paid Holidays