Melissa Hooper, quality system associate, has 2 years of experience managing and supporting regulatory and quality assurance projects. She has experience designing, populating, and maintaining ISO 13485 Quality Management Systems for startup medical device companies. Melissa is practiced in supporting 510(k) regulatory submissions.

Melissa’s qualifications include the following:

Quality Management Systems

  • Created, populated, and maintained ISO 13485 Quality Management Systems and successfully achieved ISO certification, as well as CE Mark and FDA device approvals, for those clients.
  • Developed and updated procedures to comply with ISO 13485, 21 CFR 820, MDD 93/42/EEC, SOP/98-282, and CMDCAS standards.
  • Conducted quality audits in accordance to ISO 13485, 21 CFR 820, MDD 93/42/EEC, SOR/98-282, and CMDCAS standards.
  • Performed document control for ISO 13485 Quality Management Systems

Quality Management Systems

  • Created, populated, and maintained ISO 13485 compliant quality management systems and successfully achieved ISO certification for those clients.
  • Developed and updated procedures to comply with ISO 13485, 21 CFR 820, MDD 93/42/EEC, SOR/98-282 and CMDCAS standards.
  • Conducted quality audits in accordance to ISO 13485, 21 CFR 820, MDD 93/42/EEC, SOR/98-282 and CMDCAS standards.
  • Performed document control for ISO 13485 compliant quality management systems.

Regulatory Affairs

  • Supported 510(k) writing and submissions.
  • Supported the drafting and submissions of technical bulletins.

Melissa holds a BS in Earth and Space Sciences with an Emphasis in Biology from the University of Washington.

Contact Info:
Email: mhooper@alvamed.com
Office: (888) 33 – 13485 Ext. 3