Principal Quality Systems Engineer

Location: Plymouth Salary: US$55 - US$65 per hour
Sector: Medical Devices, Quality Assurance (QA), R+D/Project Management Type: Contract

Are you a self-starter interested in working on a global project? Are you interested in playing a key role in product development and design control processes? If you answered "Yes" to these questions, I have the perfect opportunity for you!

My client, a leading provider of infection prevention products and services in the healthcare market; specializing in endoscopy, water purification and filtration, and healthcare disposables, is actively searching for a Principal Quality Systems Engineer to join its team in Plymouth, Minnesota. This will be structured as a 7 month contract and pay is competitive based on prior experience.

My client is a medical technology innovator of life-impacting solutions for over 35 years. They are looking for a Principal Quality Systems Engineer that will lead efforts to support work on a global project, multi-facility work, challenging, be a part of a multiple QMS system merge, while scratching and rewriting procedures. This individual would be working on the Global centralization of a SAP system and updating systems across the board relative to QMS and SAP rollout!

Among others, this role will take on the following responsibilities:

  • Work with Product Development team to execute risk based approach, procedure, plan to develop, design requirements, specifications, technical standards, test methods, test protocols, and test data analysis.
  • Responsible for the identification of technical standards against QSR, EPA, EU MDD, and other target market regulatory and clinical requirements.
  • Collaborate with R&D, Marketing, Regulatory Affairs, Supply Chain, and Manufacturing to ensure effective and robust risk management, testing, verification, validation, IQ/OQ/PQ as applicable for products and processes in the concept to market phases of product development.
  • Prepare oral and/or written reports of analysis for Design Verification, Design Validation, and other critical testing and evaluation activities.
  • Experience in product and process risk analysis/FMEA, specification writing, test method development, statistical analysis of quantitative and qualitative data, test report writing, and medical device design reviews.

The best candidates for this role will possess the following basic qualifications:

  • B.S. degree in Engineering or Physics
  • Software Validation Background
  • 5 plus years in a leadership position
  • Experience in SAP, ERP, or related systems
  • Experience writing test systems protocols, writing Use Case scenarios, and mapping processes is a bonus
  • Experience with process validation on QS Process, medical device design verification and validation activities
  • Experience in Project Management that includes worldwide deployment of a multi-site quality system

The Principal Quality Systems Engineer is an outstanding opportunity to take on immediate leadership and grow within a top notch organization, and Plymouth, MN is a fantastic location!

If you are interested in learning more and/or applying, please reach out to me on the details below!

Sthree US is acting as an Employment Business in relation to this vacancy.