Sr. Manager, Quality Assurance and Regulatory Affairs ( Remote USA )

Kinsa

San Francisco California

United States

Information Technology
(No Timezone Provided)

We are looking for a Sr. Manager, Quality Assurance and Regulatory Affairs to join our team!. This is a great opportunity to join an exciting, rapidly growing company with a highly collaborative and high-performing team. In this role you will lead all quality and regulatory activities for development, manufacture, and distribution of FDA Class II medical devices both within the US and internationally. This is a process management role in which the successful candidate will be able to complete initiatives leveraging internal cross-functional resources rather than direct reports. Is this role right for you? Successful candidates will be highly collaborative, employee-centric, business-focused and customer service oriented. You are flexible, reliable, trustworthy, and have excellent time management (with a sense of urgency), communication, and organizational skills. You work seamlessly across all departments within the organization as well as with suppliers, contract manufacturers, consultants, notified bodies, and regulatory agencies. Excellent communication and planning skills are a must, along with a dedication to proactively solving complex problems and continuous improvement. The ideal candidate must be able to execute on initiatives efficiently while ensuring regulatory compliance. Sound like you? keep reading..... Kinsa was founded with a mission to stop illness from spreading by knowing where and when it starts. Our mission has never been more important or more relevant than it is right now. We are leading the charge in the fight against COVID-19. Our of illness has been featured in the New York Times, on Rachel Maddow, CNBC, FOX News, The Economist, The Daily Show with Trevor Noah etc. Turn on the TV, open the paper… We are making headlines bringing our Data to the fight. We’ve done this by successfully transforming the first device you grab when sickness strikes - the thermometer - into a sensor to detect when and where illness is rising, and communicate with those who have just fallen ill. 

Responsibilities:

  •  Lead quality functions, including document control, quality control, quality assurance, quality engineering, and quality systems. The person in this position will own deployment, maintenance, and continuous improvement of the quality systems.
  • Lead regulatory compliance, including staying abreast of current and new/planned regulations, submitting new applications for regulatory approvals, interfacing with notified bodies and regulatory authorities, leading audits/inspections, and ensuring post-audit action items are completed in a timely manner
  • Lead post-market surveillance activities, including complaint investigations. Takes a data-driven approach to driving continuous improvement activities across the organization by performing internal audits and managing the CAPA process. The person in this role will serve as the Management Representative and will present quality metrics and opportunities for improvement to the senior leadership team during Management Reviews.
  • Manage all aspects of the Arena PLM system and document control. Responsible for routing change orders, ensuring required approvals, tracking pre- and post-closure tasks, and training. Maintains Design History Files, Device Master Records, and associated quality documents. Ensures product traceability and complete and accurate Lot/Device History Records.
  • Successful candidates will have demonstrated experience with development, implementation and management of company-wide Quality Systems, and hands-on experience with implementing change or upgrades to the Quality Systems used in an organization, as well as experience with both US and international regulatory submissions.
  • Offer expert-level problem solving support by using methodologies such as Failure Modes and Effects Analysis (FMEA), Gage Repeatability and Reproducibility (GR&R), Design of Experiments (DOE), Verification and Validation (V&V), Statistical Process Control (SPC), DMAIC, Ishikawa Diagrams, and other similar techniques.
  • Provide Design for Quality inputs during product development initiatives. Develops regulatory pathway for new products and changes/updates to existing products.
  • Ensure supplier quality from raw materials through mass production at contract manufacturers, including supplier selection, supplier performance monitoring and score cards, supplier corrective actions, supplier audits, and maintenance of the Approved Supplier List. Evaluates and dispositions non-conforming materials.

    • Required Skills and Experience

  • 7 or more years of quality experience in a medical device company with deep familiarity with running and maintaining a quality system.
  • Thorough understanding of US FDA Quality System Requirements, ISO 13485, European Union MDR, and Canadian medical device regulations. Must be able to research, understand, and execute against regulatory requirements in other countries, as required.
  • Working knowledge with PLM tools such as Arena.
  • Excellent oral and written communication, planning, and problem-solving skills.
  • Individual must be a hands-on, results-oriented manager and leader, who is a strong team player, and comfortable in an entrepreneurial small-company environment.
  • Must be able to follow established policies and procedures, create new procedures, and comply with regulatory requirements.
  • Experience with project and bug tracking tools: Jira, Confluence, TestRail is a plus
  • Ability to train others in Good Documentation Practices
  • BS degree or equivalent relevant work experience.
    • About Us: There are four key characteristics of our team that we hope are traits you have as well: Be Passionate : The Kinsa team is driven towards a goal that is bigger than themselves, they have a real passion in working toward a solution for a widespread social issue. Our work is stimulating, meaningful and has purpose. Be Committed: We are committed to our mission. We have a tremendous opportunity in front of us: to change the face of public health and save hundreds of thousands of lives in the process. We are committed to working hard, working smart, working together, and doing what it takes to make a difference. Our time is now. Be Efficient : We are a startup, and we are proud of our work so far but there is a lot more work to be done. Moving fast is the result of good planning, decision making, and execution. Be Inclusive : Solving one of the most important public health problems of our time requires a mix of perspectives and approaches, which is why diversity of age, gender identity, race, sexual orientation, physical ability, religious belief and ethnicity are all welcome and greatly valued at Kinsa. We are as proud of our differences as we are of our shared passion for stopping the spread of infectious illness, and are always looking for people with varied viewpoints, skill sets, backgrounds and experiences to realize our mission.

    Sr. Manager, Quality Assurance and Regulatory Affairs ( Remote USA )

    Kinsa

    San Francisco California

    United States

    Information Technology

    (No Timezone Provided)

    We are looking for a Sr. Manager, Quality Assurance and Regulatory Affairs to join our team!. This is a great opportunity to join an exciting, rapidly growing company with a highly collaborative and high-performing team. In this role you will lead all quality and regulatory activities for development, manufacture, and distribution of FDA Class II medical devices both within the US and internationally. This is a process management role in which the successful candidate will be able to complete initiatives leveraging internal cross-functional resources rather than direct reports. Is this role right for you? Successful candidates will be highly collaborative, employee-centric, business-focused and customer service oriented. You are flexible, reliable, trustworthy, and have excellent time management (with a sense of urgency), communication, and organizational skills. You work seamlessly across all departments within the organization as well as with suppliers, contract manufacturers, consultants, notified bodies, and regulatory agencies. Excellent communication and planning skills are a must, along with a dedication to proactively solving complex problems and continuous improvement. The ideal candidate must be able to execute on initiatives efficiently while ensuring regulatory compliance. Sound like you? keep reading..... Kinsa was founded with a mission to stop illness from spreading by knowing where and when it starts. Our mission has never been more important or more relevant than it is right now. We are leading the charge in the fight against COVID-19. Our of illness has been featured in the New York Times, on Rachel Maddow, CNBC, FOX News, The Economist, The Daily Show with Trevor Noah etc. Turn on the TV, open the paper… We are making headlines bringing our Data to the fight. We’ve done this by successfully transforming the first device you grab when sickness strikes - the thermometer - into a sensor to detect when and where illness is rising, and communicate with those who have just fallen ill. 

    Responsibilities:

  •  Lead quality functions, including document control, quality control, quality assurance, quality engineering, and quality systems. The person in this position will own deployment, maintenance, and continuous improvement of the quality systems.
  • Lead regulatory compliance, including staying abreast of current and new/planned regulations, submitting new applications for regulatory approvals, interfacing with notified bodies and regulatory authorities, leading audits/inspections, and ensuring post-audit action items are completed in a timely manner
  • Lead post-market surveillance activities, including complaint investigations. Takes a data-driven approach to driving continuous improvement activities across the organization by performing internal audits and managing the CAPA process. The person in this role will serve as the Management Representative and will present quality metrics and opportunities for improvement to the senior leadership team during Management Reviews.
  • Manage all aspects of the Arena PLM system and document control. Responsible for routing change orders, ensuring required approvals, tracking pre- and post-closure tasks, and training. Maintains Design History Files, Device Master Records, and associated quality documents. Ensures product traceability and complete and accurate Lot/Device History Records.
  • Successful candidates will have demonstrated experience with development, implementation and management of company-wide Quality Systems, and hands-on experience with implementing change or upgrades to the Quality Systems used in an organization, as well as experience with both US and international regulatory submissions.
  • Offer expert-level problem solving support by using methodologies such as Failure Modes and Effects Analysis (FMEA), Gage Repeatability and Reproducibility (GR&R), Design of Experiments (DOE), Verification and Validation (V&V), Statistical Process Control (SPC), DMAIC, Ishikawa Diagrams, and other similar techniques.
  • Provide Design for Quality inputs during product development initiatives. Develops regulatory pathway for new products and changes/updates to existing products.
  • Ensure supplier quality from raw materials through mass production at contract manufacturers, including supplier selection, supplier performance monitoring and score cards, supplier corrective actions, supplier audits, and maintenance of the Approved Supplier List. Evaluates and dispositions non-conforming materials.

    • Required Skills and Experience

  • 7 or more years of quality experience in a medical device company with deep familiarity with running and maintaining a quality system.
  • Thorough understanding of US FDA Quality System Requirements, ISO 13485, European Union MDR, and Canadian medical device regulations. Must be able to research, understand, and execute against regulatory requirements in other countries, as required.
  • Working knowledge with PLM tools such as Arena.
  • Excellent oral and written communication, planning, and problem-solving skills.
  • Individual must be a hands-on, results-oriented manager and leader, who is a strong team player, and comfortable in an entrepreneurial small-company environment.
  • Must be able to follow established policies and procedures, create new procedures, and comply with regulatory requirements.
  • Experience with project and bug tracking tools: Jira, Confluence, TestRail is a plus
  • Ability to train others in Good Documentation Practices
  • BS degree or equivalent relevant work experience.
    • About Us: There are four key characteristics of our team that we hope are traits you have as well: Be Passionate : The Kinsa team is driven towards a goal that is bigger than themselves, they have a real passion in working toward a solution for a widespread social issue. Our work is stimulating, meaningful and has purpose. Be Committed: We are committed to our mission. We have a tremendous opportunity in front of us: to change the face of public health and save hundreds of thousands of lives in the process. We are committed to working hard, working smart, working together, and doing what it takes to make a difference. Our time is now. Be Efficient : We are a startup, and we are proud of our work so far but there is a lot more work to be done. Moving fast is the result of good planning, decision making, and execution. Be Inclusive : Solving one of the most important public health problems of our time requires a mix of perspectives and approaches, which is why diversity of age, gender identity, race, sexual orientation, physical ability, religious belief and ethnicity are all welcome and greatly valued at Kinsa. We are as proud of our differences as we are of our shared passion for stopping the spread of infectious illness, and are always looking for people with varied viewpoints, skill sets, backgrounds and experiences to realize our mission.

    Apply