Mar 31, 2022

Quality Assurance Manager

$100,000 - $140,000 yearly
  • Desktop Health
  • Boston, MA, USA
Full time Management Manufacturing Product Development Quality Regulatory

Job Description

Desktop Health is leveraging additive manufacturing and advanced materials to personalize patient care. Desktop Health is vertically integrated to develop, manufacture and commercialize applications across a range of healthcare specialties. The company is rapidly focused on leveraging its bio printing capabilities across several key specialties.

Position Description:

The Quality Assurance Manager will work with an interdisciplinary team to document the design and commercial manufacturing process of novel 3D printed tympanic membrane grafts (PhonoGraft) and other tissue grafts as part of the Desktop Health team. We are a small team located in Boston, MA (parking available), working to improve the lives of people with tympanic membrane perforations and other medical conditions. The candidate will work under the direct supervision of the Vice President of Biomaterials and Innovation, with support from a Manufacturing Engineer, a Mechanical Engineer, a Material Engineer, and Research Technicians.

Primary Responsibilities include:

  • Lead the establishment of a Quality Management System (QMS)
  • Assist in design control activities, including the assembly of a design history file (DHF) and a device master record (DMR)
  • Review and approve design control documentation
  • Manage Quality Control activities, SOP updates, and process improvement discussions and investigations from a Quality Assurance standpoint
  • Manage supplier audits and internal audits
  • Assist in document control and management
  • Assist in the design of protocols for the sterilization and packaging of medical devices
  • Review SOPs related to manufacturing of medical devices
  • Interface with regulatory and manufacturing consultants to determine best practices
  • Ensure compliance with relevant standards

Education & Experience:

  • Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Biology, Physics, Mathematics, Computer Science, or related field
  • 3 - 8 years of experience working in the medical device industry
  • Experience working with a Quality Management System (QMS)
  • In depth familiarity with FDA, ISO, MDD, and medical device industry quality requirements associated with product design & development, product risk management, and design control

Knowledge/Skills/Abilities:

  • Familiarity working with a QMS software tool such as Greenlight Guru or Propel
  • Familiarity with FDA’s 21 CFR Part 820 and ISO 13485
  • The candidate should be highly motivated toward translational research, have a strong work ethic, and take initiative to achieve project goals with minimal oversight
  • Skilled in statistical methods and design of experiments
  • Professional written and oral communication skills
  • Experience and comfort working with 3D printers and cleanroom environments is a bonus
  • Familiar with Keyence 3D Surface Profiler System is a bonus

Desktop Health is a division of Desktop Metal. At Desktop Metal, innovation is at the core of our DNA. And we believe ground-breaking discoveries are born from diverse teams with unique backgrounds and experiences. We are committed to employing a diverse workforce with equal employment opportunities regardless of race, color, religion, sex, national origin, age, sexual orientation, gender identity, gender expression, age, marital status, veteran status, or disability.


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