Senior Design Quality Engineer

STRM Recruiting•Portland, OR

9h•$100,000 - $140,000

About The Position

STRM Recruiting is partnering with a medical device company here in Portland We are hiring a Sr Design Quality Engineer. In this role you will be part of the process that brings great technology to Medical, Dental and Veterinary markets. Specializing in the design and manufacturing of premium medical devices. Our clients ingenuity can be found in our suture technologies, sports medicine fibers and anchors, surgical lighting, and special needle technologies. The Sr Design Quality Engineer will have primary responsibility related to complaint handling, complaint analysis and operations quality support. They will collaborate and improve quality system standards and have overall responsibility to ensure the design, development and design transfer processes are executed appropriately to meet the changing needs of the global regulatory requirements.

Requirements

Bachelor Degree in Engineering or similar
CAPA planning and implementation
Use of Failure Mode Effects Analysis (FMEA)
Work experience in an ISO13485 or FDA regulated environment
Computer skills, including Word and Excel
Demonstrated technical writing skills
3+yrs experience in design assurance or design quality in new product development in an FDA regulated environment is desirable, with an understanding of cGMP, QSR, ISO13485, MDSAP, and MDR

Responsibilities

Develops, coordinates, and conducts technical product/design validation/verification studies and evaluations of engineering design concepts.
Integral member of new product development team responsible for leading activities required to ensure reliability and quality of the design and manufacturability of the product. Supports ongoing global regulatory compliance including submissions and audits (MDR, ISO 13485, FDA CFRs, etc.).
Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
Completes hazards and risk analysis studies of design and processes using ISO 14971, FMEA, and other risk management principles.
Compiles and analyzes complaints, performance reports, and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes for improvements in existing or new products.
Drives CAPA and Nonconformance investigations and ensures that corrective measures meet acceptable standards. Works cross-functionally to achieve optimal results.
Analyzes preliminary plans and develops quality assurance programs to achieve company, customer and governmental agency reliability objectives.
Ensure Design Requirements Flow down, predictive modeling, and DRM (Design for Reliability and Manufacturability) are applied.
As necessary, proposes changes in design or formulation to improve system and/or process reliability. May determine units and/or batches requiring environmental testing and specifies minimum number of samples to obtain statistically valid data.
Utilize problem solving tools using Define, Measure, Analyze, Improve, and Control (DMAIC) methodology.
Navigate FDA QSR 21 CFR part 820, EU MDR, and ISO 13485 regulations
Coordinate planning, implementation and trending of multiple quality management systems including CAPA, SCAR, and non-conformances.
Performs supplier audits.
Leads component qualifications/FAIs to ensure supplier and component requirements perform as intended, as required.
Coordinates document change process and documents
Ensures device master record, device history record, risk management file are established and meet all production requirements for commercial release.