• Senior Manager, Risk Remediation Process

    Insight Global (Bedford, MA)


    Job Description

    The Sr. Manager-Risk Management Process is responsible for managing risk processes throughout the product lifecycle, ensuring compliance with ISO 14971 standards, and collaborating with cross-functional teams. This role involves overseeing product quality and process reliability, supporting new product development and validation, and assisting with complaint investigations and resolutions of non-conforming products. The Sr. Manager also handles corrective and preventive actions (CAPA), identifying and solving diverse problems to their root cause, and implementing improvements that support business needs and goals.

     

    Additionally, the Sr. Manager manages technical staff to establish functional goals and meet assigned objectives. They are accountable for overseeing activities within the function and working closely with subordinates by providing regular guidance and direction to ensure goals are met or exceeded. The position requires leading by example in alignment with company values to achieve objectives.

     

    We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

     

    Skills and Requirements

     

    - Bachelor’s degree in engineering, Quality Management, Risk Management, or a related field.

     

    - 10 years of experience within a regulated medical device or pharmaceutical environment.

     

    - 5 years of risk management experience in the medical device industry, preferably in patient monitoring systems.

     

    - 5 years previous supervisory/management experience

    - Need experience - document owners of risk: PFMEAs- owning and changing/updating risk documentation

    - Volume? Top level risk files - 30

     

    - Low level - hundreds - remediate and update - ASQ Certified CSQE, SSBB, CQE or SQE

     

    - QMS lead auditor certificate

     

    - Master’s degree in engineering, Quality Management, Risk Management, or a related field is preferred.

    - Enterprise level experience (Abott, ThermoFisher, etc) null

    We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].