Job Description

 Riverpoint Medical in Portland Oregon is looking to hire a Quality Engineer II (Post Market). 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.  Quality Engineer II (Post Market) is responsible for monitoring and trending post-market feedback and making improvements to product quality and processes. The Quality Engineer II (Post Market) will work with production to support quality assurance, manage and resolve non-conformities, resolve customer issues, and continually improve the quality system.

Duties and Responsibilities:

• Leads and independently conducts investigations into product quality issues, non-conformities, customer complaints, and manufacturing deviations, ensuring timely and effective resolution.
• Works directly with customers, field representatives, and internal stakeholders to understand and address product-related concerns, driving improvements and enhancing customer satisfaction.
• Uses advanced problem-solving, statistical techniques and critical thinking to identify root causes of quality issues and implement long-term corrective and preventive actions (CAPAs).
• Serves as the primary investigator for escalated complaints, adverse events, and returned materials, ensuring thorough documentation and resolution.
• Analyzes trends in product quality, customer feedback, and manufacturing performance to proactively identify areas for product and process improvement.
• Drives continuous improvement initiatives to enhance product quality, reduce defects, and optimize manufacturing processes based on real-world feedback and data analysis.
• Collaborates closely with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to drive product enhancements, resolve systemic issues, and ensure compliance with global regulatory requirements.
• Conducts internal and supplier audits, ensuring adherence to quality standards and recommending improvement strategies where needed.
• Takes ownership of CAPA and non-conformance activities, ensuring timely execution, effectiveness verification, and regulatory compliance.
• Facilitate problem resolution by leading cross-functional discussions, challenging assumptions, and driving data-based decision-making to enhance product reliability.
• Supports regulatory inspections and audits by providing investigation reports, corrective action summaries, and risk assessments to demonstrate compliance with quality system requirements.
• Mentors’ junior engineers and cross-functional team members in quality system processes, problem-solving methodologies, and customer-driven quality improvements.
• Ensures compliance with company policies, regulatory requirements, and industry best practices.
• Additional responsibilities may be assigned at the manager’s discretion.

Qualifications:

• BS (engineering preferred) with 5+ years related experience in the medical device industry or MS engineering and 2+ 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 9 company paid holidays, referral 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.