Senior Quality Engineer bei Riverpoint Medical

 Riverpoint Medical is looking to hire a Senior 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 Senior Quality Engineeris responsible for finished device manufacturing, work-in-progress (WIP), and incoming inspection. Your expertise will play a key role in actively engaging with the development, maintenance, and enhancement of our quality management system, ensuring that every component, assembly, and finished product consistently meets or exceeds established quality requirements. You will proactively drive improvements to our quality systems and manufacturing processes, contributing to the ongoing evolution of our quality initiatives. Collaborating closely with operations, you will uphold the highest standards of product quality, manage and resolve non-conformities, lead process improvement initiatives, address customer issues, and champion continuous improvement activities within the quality system.

Duties and Responsibilities for the position include:

• Develops, modifies, applies and maintains quality standards for processing materials into sub-assemblies or finished materials product.
• Collaborates with development engineering and manufacturing functions to ensure quality standards are implemented.
• Provide input to and approve IQ/OQ/PQ validation protocols and reports
• Perform risk assessment activities to identify product quality or compliance risks and lead efforts to mitigate those risks
• Develops and implements methods and procedures for inspecting, testing and evaluating raw materials, products and production equipment and improving methods, when required.
• Implement approved changes using quality engineering principles and fully document them in compliance with Riverpoint policies and procedures
• Improve upon process controls related to raw material and manufacturing acceptance activities, Finished Device packaging, labelling and sterile product management, including aspects such as label reconciliation, segregation and material flow controls, and lot release activities
• Lead process improvement activities through the non-conformance and CAPA programs as well as independent continuous improvement projects
• Participate in the timely processing of complaints, non-conformances, returned materials and corrective actions
• 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 including supplier CAPAs, scorecards, and supplier audits
• Lead internal audits of the quality management system
• Promote compliance to company procedures
• May manage teams consisting of quality personnel supporting product testing/release

Education and Qualifications

• Engineering degree with 5+ years related experience in a regulated environment (ISO 13485, FDA), preferably medical device manufacturing
• Product failure investigations
• Use of Failure Mode Effects Analysis (FMEA)
• Computer skills including Word, Excel, Powerpoint
• Basic project management skills
• Demonstrated proficiency in technical writing (procedures, reports, etc.)
• Knowledge of cGMP, QSR, ISO 13485, MDSAP and MDR
• Proficient in English 

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 9 company paid holidays.

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.