Riverpoint Medical in Portland Oregon is looking to hire a
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
Quality Engineer(QE) is responsible for driving proactive improvements to quality systems and processes. The QE will work with production to support quality assurance, manage and resolve non-conformities, validate processes, resolve customer issues, and continually improve the quality system.
Duties and Responsibilities: - May provide oversight and ensure timely execution of the complaint handling process
- May responsible for all complaint analysis activities and trending.
- May collaborate with Regulatory on Medical Device Reporting (MDR) and adverse event reporting requirements
- Coordinate planning, implementation and trending of multiple quality management systems including CAPA, SCAR, and non-conformances.
- Perform internal and supplier audits
- Assist in the writing and execution of system validation plans
- Promote compliance to company procedures
- Support process validation studies for special processes and drive a reduction in Riverpoint Medical's reliance on inspection/verification as a quality assurance methodology
- Develop and execute IQ, OQ and PQ protocols for product, processes, and equipment within the facility
- Write reports summarizing results and statistics for all equipment, product, or process validation projects. Assist production with equipment installation and maintenance
- Improve upon process controls related to Finished Device packaging, labelling and sterile product management, including aspects such as label reconciliation, segregation and material flow controls, and lot release activities
- Participate in the timely processing of complaints, non-conformity, returned materials and corrective actions
- Assist in investigations of incidents related to Riverpoint Medical products and appropriate reporting of such events to US and foreign regulatory authorities and notified bodies, as applicable
- Assist in QA/RA, production and product development personnel in formatting and compiling quality system documents
Education and Qualifications - BS (engineering preferred) with 3+ years related experience in the medical device industry or MS engineering and 0+ years related experience, or equivalent experience
- Complaint analysis activities and product failure investigations desirable
- CAPA planning and implementation desirable
- Use of Failure Mode Effects Analysis (FMEA) desirable
- Work experience in an ISO13485 or FDA regulated environment desirable
- Computer skills, including Word and Excel
- Demonstrated technical writing skills
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.
