Riverpoint Medical in Portland Oregon is looking to hire a Quality Director. 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 Quality Director at Riverpoint Medical will lead and manage the quality management system (QMS) to ensure all products meet stringent regulatory, safety, and performance standards. This role involves overseeing compliance with ISO 13485, FDA regulations, and other international standards. You will be responsible for developing and implementing quality assurance strategies, including risk management and continuous improvement initiatives. The Quality Director will work cross-functionally with engineering, production, and regulatory teams to ensure quality control at every stage of product development and manufacturing. Additionally, you will lead audits, manage non-conformances, and drive corrective actions while maintaining a culture of quality and compliance throughout the organization. Your leadership will be critical in delivering safe, effective, and innovative medical devices to market.
Responsibilities:
- Oversee the implementation and maintenance of the Quality Management System (QMS) at the site, ensuring compliance with Quality policies, including training, internal audits, CAPAs, complaints, change control, document control, incoming inspection, and manufacturing oversight.
- Drive continuous improvement initiatives to optimize quality procedures and compliance projects, ensuring harmonization, simplification, and alignment with global standards.
- Lead, mentor, and develop quality staff, providing ongoing performance feedback and training opportunities.
- Ensure timely resolution of quality issues that are risk-based and in compliance with all internal processes and regulatory requirements.
- Define, implement, and improve policies and procedures related to the Quality Management System.
- Lead cross-functional projects to drive quality and operational excellence continuous improvement initiatives.
- Proactively identify risks and potential issues, implementing preventive actions across the site to mitigate adverse impact on quality and operations.
- Lead FDA, international regulatory, and customer audits.
- Develop and manage departmental headcount and alignment with business objectives.
- Collaborate on new product development, engineering designs, manufacturing processes, and quality assurance strategies to ensure high-quality products and processes.
- Prepare and analyze quality performance KPIs, identifying trends, opportunities for improvement, and maintaining adherence to quality assurance policies and regulatory standards.
- Maintain professional and technical expertise by staying updated on industry trends, attending educational workshops, and participating in relevant professional organizations.
- Lead the development and implementation of receiving inspection standards, devising testing methods and procedures to ensure product quality from raw materials through final product release.
- Demonstrate leadership in change management and cross-functional team collaboration.
- Demonstrated proficiency in leading cross-functional teams.
- Demonstrated ability to lead change and implement sustainable solutions.
- Ability to motivate and energize the team for quality improvement through strong interpersonal and leadership skills.
Education and Qualifications:
- 5+ years of leadership in quality assurance in an FDA regulated environment is desirable, with an understanding of cGMP, QSR, ISO13485, MDSAP, and MDR.
- Bachelor's degree in engineering or related discipline or equivalent work experience.
- Strong knowledge of GMP/GDP in both domestic and international regulatory environments.
- The preferred candidate has a demonstrated history of quality system analytics, leadership, collaborative team working experience, project management, QC/QA.
- Strong written and verbal communication skills.
- Experience with MS Word, Excel, ERP, and statistical software (e.g. Minitab) preferred.
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.
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.
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