- 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.
- 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
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Senior Design Quality Engineer - Portland, United States - Riverpoint Medical
Description
Job Description
Job DescriptionRiverpoint 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.
Duties and Responsibilities:
Education and Qualifications
We offer great benefits: Medical, Dental and Vision, Life and Accidental Death Insurance; 401(k) with company match and immediate vesting, Paid Time Off and 8 company paid holidays. We also reward our team with bonus pay such as Referral Bonus and Annual Bonus
Riverpoint Medical is committed to a diverse and inclusive workplace. Riverpoint Medical is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.
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