Riverpoint Medical is looking to hire a **Quality Engineer **for our new facility in Costa Rica. 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** is responsible for driving proactive improvements to quality systems and processes. The QE will collaborate with Operations and Engineering to ensure product quality and conformance to specifications, manage and resolve non-conformities, lead process and equipment validations, resolve customer issues, and drive continuous improvement activities in the quality system.
**Duties and Responsibilities for the position include**:
- Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
- 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.
- Perform internal and supplier audits.
- Perform risk assessment activities to identify product quality or compliance risks and lead efforts to mitigate those risks.
- Create and update SOPs, WI, and forms, as necessary.
- Implement approved changes using quality engineering principles and fully document them in compliance with Riverpoint policies and procedures.
- Assist in investigations of quality events related to Riverpoint Medical products and appropriate reporting of such events to US and foreign regulatory authorities and notified bodies, as applicable.
- Lead supplier performance management activities in support of established quality standards
- Promote compliance to company procedures.
- Other responsibilities as assigned.
**Education and Qualifications**
- Work experience in an ISO13485 or FDA regulated environment.
- Familiarity with NCR and CAPA systems
- Product failure investigations
- Use of Failure Mode Effects Analysis (FMEA)
- Excellent verbal and written communication skills
- Computer skills, including MS Word, Excel, and PowerPoint
- Demonstrated technical writing skills.
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.
