Intermediate Quality Specialist

5 months ago

Vancouver, Canada Prenuvo Full time

**About Us**

At Prenuvo, we are on a mission to flip the paradigm from reactive "sick-care" to proactive health care. Our award-winning whole body scan is fast (under 1 hour), safe (MRI has no ionizing radiation), and non-invasive (no contrast). Our unique integrated stack of optimized hardware, software, and increasingly AI, coupled with the patient-centric experience of our clinics across North America, have allowed us to lead the charge against "we caught it too late again." Prenuvo operates preventative screening clinics in Vancouver, Silicon Valley, Dallas, Boca Raton, Minneapolis, Los Angeles, New York City, Bethesda, and Chicago, with more clinics in North America and internationally in the next 2 years.

**The Opportunity**

We are changing healthcare and bringing a slow moving goliath of an industry into the present while blazing a trail into the future of radiology and clinical operations through software, automation and AI.

We are looking for an **Intermediate Quality Specialist** **to support & coordinate SOP training, document control and configuration management, as well as internal quality audits to comply with ISO-13485 and MDSAP Quality Management System as defined by our corporate strategy. Help reshape the world through proactive healthcare while working with cutting-edge technology and high performing teams with deep expertise - join us to make a difference in people's lives

**What You'll Do**

Reporting to the Head of Regulatory Affairs and Quality, the Intermediate Quality Specialist will perform internal quality audits & train staff to Prenuvo's ISO 13485/MDSAP Quality Management System(QMS). The Intermediate Quality Specialist will maintain a document revision control and numbering system, perform internal audits of all policies, procedures, work instructions and forms and maintain the Quality Manual with associated SOPs as defined by our corporate strategy.

**Duties**

**Quality Management System (QMS) Compliance**:

- Audit procedures and train employees using medical device quality standards.
- Demonstrate compliance with Prenuvo's ISO 13485 QMS

**Document Control**:

- Maintain revision control of policies, procedures, work instructions, and forms, including DHF/DMR/RMF
- Implement document, data, and records configuration control throughout the medical device product lifecycle
- Comply with document control standards (21CFR 820.40 and ISO 13485:2016 Section 4.2.4)
- Ensure only approved, current documents are used, and establish a framework for document approval, updates, publication, and obsolescence

**Training and Education**:

- Maintain an updated training matrix by job function, including a curriculum database and training records
- Execute a training program for cross-functional team members compliant with ISO 13485/MDSAP/ISO 42001
- Schedule and provide necessary information for employee training sessions

**Device Master Records (DMR), Design History Files (DHF), and Risk Management**:

- Build and maintain a DHF index for each product.
- Centralize medical device compliance standards, perform standards change assessments, and coordinate impact analysis
- Maintain Configuration Control of all DMRs, DHFs, and Risk Management Folders in accordance with SOPs

**Internal Quality Auditing**:

- Perform internal quality auditing activities as per the annual schedule.
- Conduct audits for each ISO 13485 element, including planning, evidence collection, and presenting audit reports.

**Strategic Input**:

- Provide valuable input to Prenuvo's corporate strategic plan based on your understanding of SaMD quality standards and regulations.

**What You'll Bring**

**Experience**:

- Bachelor's degree in Science, Engineering, or Medical Technology
- Preferred certifications: Internal auditor certification and/or CMDA (ASQ)
- 5 years in medical device Quality Assurance
- Audited a minimum of 20 standard operating procedures and work instructions; eQMS experience is preferred
- Familiarity with front room/back room audit team set-up
- Analytical experience assessing all aspects of a quality management system's adherence to ISO-13485
- Experience in training employees with a SaMD-focused QMS
- Auditing experience in US/EU/Canada medical device quality standards and regulations
- Experience working collaboratively across various departments, including Software Development, Clinical, Project/Product Management, Marketing, Regulatory Affairs, Labeling, and Legal.
- Proficiency in controlling quality SOPs and product records, particularly in areas such as product design control, V&V testing, and risk management.
- Skilled in performing internal quality audits to ensure an "always audit-ready" ISO-13485/ISO-42001 compliant Quality Management System (QMS).
- Familiarity with regulatory requirements, including those of US FDA, Health Canada, and EUMDR/UKCA certification organizations.
- Experience customizing training curricula based on employees' roles to meet the specific requirements

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