Quality Engineer

MEDISISS - Redmond, Oregon Area

Posted 683 days ago
  • Experience
  • Job function
  • Employment type
  • Industry
    Medical Devices
  • Job ID

This is a preview of the Quality Engineer job at MEDISISS. To view the full job listing, join LinkedIn - its free!Join LinkedIn - its free!

About this job

Job description

Position Summary:
Uses Quality Engineering principles, tools and techniques to develop, review and/or optimize systems and processes so that they are aligned with the overall Company strategy and mission effecting continuous quality improvement. Coordinates or performs testing to verify equipment and processes comply with current MEDISISS procedures, and appropriate regulations and standards (i.e., QSR, ISO-13485, AAMI, ANSI, ETC.). Develops and maintains all associated documentation. Assists in process and product improvement projects and provides technical input and assistance, helps ensure MEDISISS is compliant with regulatory requirements and quality assurance tasks with regard to the development of new products/processes for reprocessing as well as the continued maintenance of current process validations. Coordinate activities with appropriate Departments to ensure validation testing is in line with regulatory requirements and manufacturing needs.

Essential Functions: The tasks include but are not limited to the list below.
1. Assists in researching device usage and device regulatory requirements to determine viability of reprocessing for new products;
2. Creates and implements validation protocols, testing protocols and executes and/or aids in the execution of cleaning, sterilization, packaging and performance testing of new & existing products and processes;
3. Develops and uses tools such as process flow charts, failure modes effects analysis (FMEA), control plans, validation plans, to quote and communicate validation requirements to the project team.
4. Reviews/analyzes data & documentation, Supports, consults, trains and leads quality improvement projects throughout the life cycle of MEDISISS products, including product design and development, manufacturing, and purchasing.
5. Utilizes Quality Engineering tools and techniques to establish sampling plans, develop quality plans, conduct and participates in Risk Management activities, supports engineering activities, conducts process and systems audits, develops specifications.
6. Analyzes routine and test data for improvement opportunities. Designs and implements experiments (DOE's) for process and product improvement and validation testing as required/needed.
7. Evaluates manufacturing quality performance capability and develops criteria to monitor and
improves existing processes.
8. Investigate instances of nonconforming material and facilitate the determination of root cause,
corrective action/preventive action and recommendation of disposition for the material review board.
9. Develop personal performance objectives based upon MEDISISS quality objectives, reporting
monthly on progress made against those goals.
10. Has a working knowledge of the Quality System Regulation (21 CFR PART 820) as well as
ISO 13485 and ISO 14971 requirements.

Desired Skills and Experience

Minimum Education & Experience:
* Bachelor of Science Degree (Engineering, Life Sciences, etc.)
* Certified Quality Engineer (CQE) strongly preferred
* Career Readiness Certification a plus
* Minimum 2 years' experience and/or training or equivalent combination of education and experience
* Experience in medical device manufacturing preferred
* Strong proficiency in MS Word, Excel, Outlook

Please email: cover letter, resume and salary requirements. No phone calls please.

About this company


MEDISISS, a Redmond, OR company, is a growing FDA-registered, Third-Party Medical Device Reprocessor of Single-Use Devices (SUDs) with an unwavering commitment to patient safety, surgeon satisfaction and FDA compliance. MEDISISS's services significantly reduce healthcare costs while promoting environmental sustainability. Total compensation includes competitive salary and excellent benefits, and beautiful Central Oregon offers great lifestyle options for everyone. Be a part of something exciting and fulfilling!

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