The Sr. Quality Engineer shall provide technical, quantitative, and coordination support to assure products and processes are designed, deployed, and operated according to requirements. Work-scope of this position includes Quality Engineering support for the Design Control and Risk Management process.
Ensure consistent implementation, improvement and compliance to the NanoString
Quality System and global regulatory regulations including, but not limited to;
the FDA Quality System Regulation (QSR), Canadian Medical Device Regulatory
(CMDR) ISO 13485 and In-Vitro Diagnostics Directive (IVDD).
Individual is a team player participating on design transfer project teams to
provide leadership in the design control and risk management process in a class
II and class III IVD reagent and instrument manufacturing facility. Challenges
include working among different business units within the company.
Additional Desired Qualifications Include:
- BS degree in a technical field, master’s degree preferred
- ASQ certified CQE preferred
- Proven experience providing quality engineering leadership to project teams in the areas of Design Controls and Risk Management.
- A complete understanding of Quality Systems from design control to release of finished product, including a working knowledge of FDA 21 CFR 820, ISO 13485, the EU MDD and CMDR
- Requirements include good manufacturing practices under USFDA 21CFR820, ISO 13485, MDD, Health Canada and corporate standards
- Proven experience in in vitro diagnostic required culminating in a successful 510(k)/PMA
- Proven ability to perform Process flow and risk assessments
- Proven ability to technically review all design documentation for acceptability prior to transfer to manufacturing.
- Ability to Support CAPA and Complaint investigations.
- Working knowledge of the elements of design transfer and production
- Working knowledge of statistical techniquesProven ability to create document plans, test procedures, bills of material, which are required for successful transition of product design to manufacturing and operations.
- As part of the design control team, train personnel in quality requirements
- Experience with non-conforming materials, returned product and service
- A working knowledge of the elements of lean manufacturing and workflow analysis
- 8-10 years of experience in the med-tech field with experience in new product introduction to the market.
- Certified Auditor a plus
- Knowledge of FDA Quality System Regulation (QSR) with an emphasis on Design Controls
- Working knowledge of software integration
- Working knowledge of nucleic acid assay development a plus.
Nanostring Technologies, Inc. - 15 months ago