Senior Design Quality Engineer

RIVERPOINT MEDICAL LLC • Portland, OR

111d

About The Position

Riverpoint Medical in Northeast Portland is hiring a Sr Design Quality Engineer. At Riverpoint you will be part of the process that brings great technology to Medical, Dental and Veterinary markets. We specialize in the design and manufacturing of premium medical devices. Our ingenuity can be found in our suture technologies, sports medicine fibers and anchors, surgical lighting, and special needle technologies. The Riverpoint 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+ years 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.
• Proposes changes in design or formulation to improve system and/or process reliability.
• Determines units and/or batches requiring environmental testing and specifies minimum number of samples to obtain statistically valid data.
• Utilizes problem solving tools using Define, Measure, Analyze, Improve, and Control (DMAIC) methodology.
• Navigates FDA QSR 21 CFR part 820, EU MDR, and ISO 13485 regulations.
• Coordinates 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.

Benefits

• Medical, Dental and Vision insurance.
• Life and Accidental Death Insurance.
• 401(k) with company match and immediate vesting.
• Paid Time Off.
• 8 company paid holidays.
• Referral Bonus.
• Annual Bonus.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 51-100 employees