Quality Engineer

2 weeks ago

Riverdale, United States Medcura, Inc. Full time

Medcura, Inc. is an innovative medical device company dedicated to advancing wound care solutions that improve patient outcomes and reduce healthcare costs. Leveraging rapid-acting, plant-based hemostatic agents with natural biopolymers, Medcuras products address a broad spectrum of bleeding scenarios, from surgical applications to everyday wounds. At the heart of its mission, Medcura focuses on enhancing patient care through technology and innovation, making it a leader in the development of effective, safe, and fast-acting wound care management solutions. Joining the Medcura team means being part of an organization committed to making a significant impact in healthcare and patients lives worldwide.

Under the direct supervision of the Vice President of Quality, the Quality Professional works with cross functional teams to execute direction for the companys Quality compliance requirements on new and existing devices. This position is responsible for the day-to-day execution of all Quality System requirements to stay CFR compliant.

Responsibilities

  • Support the development of the Companys quality objectives and work with the company employees to ensure CFR compliance
  • Participate in regulatory and quality audits of manufacturing partners, suppliers, and vendors as required to maintain ISO/QSR compliance
  • Collaborate with internal and external partners e.g., laboratories, manufacturers, and packagers, to provide medical devices that meet quality requirements for new and existing products
  • Work with product development and operations to design and produce labeling, work instructions, test methods, and instructional and promotional materials that comply with quality requirements
  • Perform administrative activities associated with the department. This will include DHR review, NCR and CAPA generation, processing, creation of quality records, risk assessment, ownership of all document control workflows, and support Management Review.
  • Analyzes process non-conformances and implements comprehensive corrective and preventive action plans
  • Support the quality system maintenance per all applicable medical device regulations, including QSR, ISO13485, MDSAP, and other standards
  • May be the primary or sole contributor to a quality specialization (i.e., Validation, Quality Control, Document Control, etc.)
  • May train and/or direct Quality Specialists or Technicians
  • Provide training in current industry quality practices. Leverages training and participation in professional quality organizations and conferences to disseminate to Medcura employees
  • Medcura is a startup entrepreneurial environment, and each employee may be asked to assist in work in areas outside of their usual duties.

Requirements

  • Four-year degree in engineering or related technical degree. Minimum four years of relevant work experience in the medical device field or related industry.
  • Demonstrates competencies and ability to support Medcura corporate objectives
  • Experience in process improvement engineering or product/process improvement areas is preferred
  • Experience in Quality function or responsibility for ownership of quality system elements within the role(s) is preferred
  • Working knowledge and understanding of QSR, ISO , FDA and EU MDR and other medical device industry quality requirements. Must be able to understand and apply regulated principles in work experience
  • American Society of Quality (ASQ) certification (CSQE, CQE, CQA, etc.) is a plus/preferred
  • Ability to follow instructions in performing repetitive tasks. Attentiveness in performing tasks
  • Ability to work as a team member in manufacturing and quality custom polymer-based gels
  • Excellent verbal and written communication skills
  • Collaborative individual with strong people skills, management, and leadership skills
  • Strong leadership, excellent organizational skills, and a good blend of discipline and creativity
  • Solid analytical skills and the ability to solve problems quickly
  • Knowledge of chemical processing and batch production
  • Commitment to Medcura with the ability to function within a start-up environment
  • Skilled in Microsoft Office (Word, Excel, PowerPoint, and Outlook)
  • Understanding of FDA requirements and ISO 13485

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