QE II- Biotech
Open to Biotech or Med Device Candidates
Rapidly growing company in the biotech space
About Our Client
Our client is a bioprocessing-focused life sciences company.
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.
- Serve as a Subject Matter Expert for application of Design Controls in accordance with regulatory expectations (e.g., Quality System Regulation, ISO standards, ASME BPE, CE, BPOG etc.). Ensures the comprehensive completion of risk management, Design Verification, and Process/Design Validation activities for products and processes. Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other multi-functional product development team members.
- Lead the effective deployment of Quality Engineering tools for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
- Ensure active and thorough investigation of quality issues identifying root causes and implementing corrective actions. Identifies and controls manufacturing process defects (scrap, nonconforming material, customer complaints).
- Ensure the development and validation of appropriate test methods for product and process performance
- Effectively utilizes Lean and Six Sigma methodologies as appropriate to achieve optimal results
The Successful Applicant
- At a minimum, a BA/BS degree (in a Biological Science, Engineering, or Physical Science requires).
- Experience with electro-mechanical hardware and associated control systems and HMI
- Understanding of the basics of cell culture and filtration and chromatography operations in a bioprocess setting is required for this position
- Certified Quality Engineer (ASQ CQE, CRE or equivalent) preferred
- Minimum of 3-5 years' experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalent
What's on Offer
Open to biotech or med device candidates