Quality Director

19 hours ago

Portland, Oregon, United States RIVERPOINT MEDICAL LLC Full time
Job Title: Director of Quality

Riverpoint Medical LLC is seeking a highly skilled Director of Quality to lead our quality management system and ensure compliance with regulatory standards.

Job Summary

The Director of Quality will be responsible for overseeing the implementation and maintenance of our Quality Management System (QMS), ensuring compliance with quality policies, including training, internal audits, CAPAs, complaints, change control, document control, incoming inspection, and manufacturing oversight.

Key Responsibilities
  • Develop and implement quality assurance strategies, including risk management and continuous improvement initiatives.
  • 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.
Requirements
  • 5+ years of leadership in quality assurance in an FDA regulated environment is desirable, with an understanding of cGMP, QSR, ISO13485, MDSAP, and MDR.
  • Bachelors degree in engineering or related discipline or equivalent work experience.
  • Strong knowledge of GMP/GDP in both domestic and international regulatory environments.
  • Strong written and verbal communication skills.
  • Experience with MS Word, Excel, ERP and statistical software (e.g. Minitab) preferred.
What We Offer

Riverpoint Medical LLC offers a competitive salary and benefits package, including medical, dental, and vision insurance, life and accidental death insurance, 401(k) with company match and immediate vesting, paid time off, and 8 company paid holidays.

We are an equal opportunity employer and do 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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