Senior/Staff Quality Engineer
Our client is a Med Device start-up with a product that is so far outside of the “me too” category that they’re on the other side of the Big Green Wall. So, now that you know what part of the country they are in, you also know that the I-90 corridor is a hub for start-ups and a place you want to be.
This is a critical, senior quality engineering role, requiring a strong background in Med Device from Design Control to Process Validation to Quality Assurance. The client has several projects on the cusp of full commercialization and what that means to you is you’ll need to hustle. While you may need occasional guidance this is the kind of position where you need to be self-driven; you need to know when to ask for permission and when to ask for forgiveness.
In the words of the hiring manager, you need to be “proactive, competent, confident and calm”. (Where do you fall in the 4 Stages of Competence?) With the years’ of experience we’re looking for, your willingness to do what it takes to get the job done will set you apart from the herd. Your skills need to be demonstrable but your constrained presentation of your value-add will be critical to your success.
- Is the Quality Partner to the NPD teams; will lead Risk Management activities; will be centrally involved with V&V and Design Transfer
- Must have a strong background in/knowledge of Design Control and Design Assurance, i.e. in-depth knowledge of ISO 13485 and 21 CFR 820
- Demonstrates collaborative skills, working with ME’s to ensure outputs meet all of the demands of quality, quantity, and timeliness
- Understands how to implement the tools of Process Control like V&V, DOE, IQ/OQ/PQ, GR&R, and SPC
- Responsible to administer Non-Conforming, CAPA, and Complaints
- Leads and reports on Post-Market Surveillance
- Heavily involved in process and/or product improvement efforts utilizing tools like Lean and Six Sigma
- Creates/Implements new and/or maintains QS documents
- BS in Engineering, the Sciences or other related discipline
- +5 years of hands-on Med Device Design and Manufacturing experience
- Demonstrable knowledge of ISO 13485 and 21 CFR 820
- Strong mathematics skills including data analysis, statistics, critical reasoning
- Knowledgeable in the use of Minitab, CAD systems, and the MS Office Suite
- Highly self-motivated with excellent organizational skills
- Leads via influence