QA/ra Manager - Montréal, Canada - Eli Health

Description

About us
Eli empowers women to understand their body and the transitions it goes through every day, and across their lives. Hormones are at the core of women's reproductive and general health, yet they remain a black box.

Eli unlocks this box by developing a device that uses saliva to capture daily hormone fluctuations at home, and an app that puts insightful hormonal data in women's hands so that they can take control of their health at every stage of their lives.

We are a diverse, deliberate, and fast-moving team driven by our mission.

You will work with a small group of experienced engineers, scientists, and entrepreneurs building novel technology and bringing it to the market to shape the future of women's health.

Eli is a venture-backed early stage startup and women-led company. To learn more about us, you can visit our website or check out recent press articles here and here.


About the role
Eli is looking for a QA/RA Manager. You will be leading the implementation of our quality management system (QMS) for MDSAP certification.

In this role, you will own and support a number of key QMS processes and be at the forefront of making strategic and operational medical device quality decisions.

Your primary responsibilities will be to:

• Develop, implement, and maintain Eli's QMS according to ISO 13485, FDA CFR Part 820 and other relevant standards and regulations.
• Create QMS processes and procedures (i.e., document control, training procedures, and owning internal audits).
• Implement and maintain the electronic QMS system that supports the assigned processes and procedures.
• Work with the CTO to define, communicate, and meet Quality Policies and Objectives.
• Coordinate and lead Eli through internal and external audits.
• Prepare and implement documentation for regulatory submission.
• Survey the postmarket landscape and assure regulatory requirements are continually met.
• Review and approve process design documents, such as process validation and process control.
• Maintain the quality & safety standards required of the medical device industry during the development of products.
• Work with the team to train and ensure compliance with the QMS.
• Ensure and promote adequate implementation of QMS procedures within the company.
• Implement and maintain riskbased approaches to the QMS processes
• Provide training to new and existing employees on QMS and regulations
• Support the design and development and production teams to ensure compliance to applicable medical devices regulations and requirements, including risk management processes (ISO and software lifecycle processes (IEC 62304)
• Ensure oversight of the Design History File (DHF) and Device Master Record (DMR)
• Ensure the development, maintenance and analysis of key performance indicators and trends, propose and followup on initiatives to improve the organization's performance;
• Conduct supplier audits and qualifications

This description is not exhaustive. We are looking for a leader that has experience implementing a QMS from product conception to product realization.


About you

• You have a Bachelor's degree in Engineering (preferred), Science or related field.
• You have 35 years of QA/RA experience in the medical device industry or related experience from regulated industry.
• You understand quality requirements laid out in ISO 13485 and in FDA CFR Part 820.
• You have excellent knowledge and understanding of international standards such as ISO 13485, ISO 14971 and IEC 62304, as well as other relevant standards.
• You have experience in dealing with representatives from the FDA or other regulatory agencies.
• You are a rigorous, diligent and thorough reviewer of quality documentation.
• You are open and willing to develop practical approaches to quality and regulations.
• You have basic IT and software skills necessary for supporting an electronic QMS system.
• You have excellent verbal and written communication skills.
• You are able to work both independently and collaboratively with multidisciplinary team members.
• You have experience managing people, internal teams and/or contractor partners.

- (Advantage) You have formal training in QMS activities such as internal auditing, ISO 13485, and relevant regulations (i.e., Quality Engineering Certification (ASQ)).

• You're passionate about building a company with the potential to positively impact women's health and advance our understanding of it.
• You're excited to continuously learn about women's health and why we need to change the status quo.
• You love the scrappy earlystage startup phase and value having a widereaching impact in an ambiguous, constantly evolving, and fastpaced environment.
• You think creatively about openended problems and solve them proactively; you have the talent and work ethic to drive your own work.

If you don't exactly match the description but still believe you are the right person to join the team, please reach ou