Quality Manager

Job Location

14 Arrow St, Cambridge, MA 02138, USA

Job Type

Full Time

Category

Regulatory

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About the Role

Job Description:

Iterative Scopes is seeking a Quality Manager responsible for compiling content and tracking the status of deliverables related to Quality Management System (QMS), Audits, Training, Quality Reviews and Process Standardization efforts. This role will provide exposure to all aspects of the Medical Device Quality Management System.


The Quality Manager will work closely with leaders across Iterative Scopes to help the company set and adhere to its QMS.


This is a great opportunity for anyone interested in managing the quality and compliance system for a fast-growing medical device company.

Key Responsibilities:

  • Manage all Quality Control activities, SOP updates, process improvement discussions and investigations from a Quality Assurance standpoint.

  • Actively participates on cross-functional team projects in a structured business environment in accordance with internal procedures and external regulations.

  • Monitors compliance with company policies, procedures and applicable regulatory requirements.

  • Lead company through Internal/External audits, generating reports with corrective action plans and ensuring implementation of corrective actions in a timely fashion.

  • Plans, executes, reports and follows-up on Management Review actions, CAPA actions, NCR or Audit Observations.

  • Conducts QMS training and maintains personnel files and all training record forms.

  • Maintains all QMS documentation including supplier evaluation, change orders, purchasing order and CAPA reports on an electronic QMS system.

Requirements

Minimum Qualifications:

  • Bachelor’s Degree

  • 4+ Years Work Experience in quality management.

  • Experience with Quality Systems based on 21 CFR 820 and ISO 13485 Quality System Requirements.

  • Experience with electronic Quality management systems.

Preferred Qualifications:

  • Graduate degree in a related field.

  • Software as Medical Device (SaMD) experience is a plus but not required.

  • Experience with ISO-14971, 62304, 62388.

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About the Company

Company Mission:

Iterative Scopes is an early-growth stage startup on a mission to revolutionize the treatment of gastrointestinal diseases with computer vision. We are backed by leading venture firms, top pharmaceutical companies as well as category defining healthcare leaders including; Obvious Ventures, Eli Lilly, Janssen Pharmaceuticals, Founders of Flatiron Health, Livongo, Path.AI, PAIGE, WHOOP!, Okta, and Recursion Pharmaceuticals.


Iterative Scopes is a venture backed company established by Jonathan Ng, MD a second time founder. The scientific advisory board includes world-class gastroenterologists and leading MIT computer vision and machine learning researchers and faculty.

Additional Info: 

The Iterative Scopes advisory board includes leading MIT computer vision and machine learning researchers/faculty and world-class Boston-area physicians and gastroenterology experts.oston-area physicians and gastroenterology experts.

Recruitment & Staffing: 

Agencies - Iterative Scopes does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Iterative Scopes or its employees is strictly prohibited unless contacted directly by Iterative Scopes' internal operations team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Iterative Scopes, and Iterative Scopes will not owe any referral or other fees with respect thereto.