Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, California, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom simplifies and improves diabetes management around the world.
Summary:
Manages the Corporate Quality Management System and Corporate Quality Training. Leads cross-functional teams in QMS site integrations, transition to new regulations, implementation of learning management systems, and scaling projects to support rapid growth. Maintains and improves the QMS to ensure compliance to regulatory requirements while keeping procedures efficient to support business needs. Establishes operational objectives and work plans.
Functional Description: Management
Manages the ongoing preparation, testing and monitoring of compliance with government regulations and regulatory agencies for the organization. Directs and performs evaluation of internal operations, controls, communications, risk assessments and maintenance of documentation as related to regulatory compliance and recommends appropriate changes. Reviews and evaluates results of internal and external audits and advises organization on appropriate actions to be taken. Directs and manages organizational relationships and interactions with regulatory agencies. Selects, develops and evaluates personnel to ensure the efficient operation of the function.
Essential Duties and Responsibilities:
Manages and supervises resources in the areas of Quality Compliance and QA Training to maintain and scale the QMS and QA training system.
Oversees QMS changes and transition to new regulations, ensures cross-functional review and collaboration between sites. Provides guidance to change originators to comply with regulatory requirements, scope can be large scale projects, significant quality systems changes, or day to day general questions.
Leads QMS integration of new sites by performing comprehensive analysis and collaborating with OUS sites to identify applicability of procedures and training requirements.
Leads improvement efforts on current QA training system and supports effective implementation of next generation Learning Management System.
Champions and leads projects and change initiatives to solve problems by collaborating with other departments.
Continuously improves processes in support of the QMS and QA Training.
Supports internal and external audits by leading front/back rooms and answering audit questions.
Supports Corporate Management Review by overseeing compilation of data and generation of quarterly report.
Provides input to strategic decisions that affect the functional area of responsibility
People management responsibilities include hiring / terminations, performance reviews, career development coaching and compensation decisions
Required Qualifications:
Proven track record in Medical Device Industry in the areas of Quality Management Systems/Quality Assurance.
In-depth knowledge of Medical Device Regulations (ISO 13485:2016, EU MDR, FDA CFR part 820, etc.).
Knowledge and experience in Electronic Training Systems in medium to large size companies.
Ability to manage projects, teams, maintain timelines, and execute projects in fast paced environment.
Proven experience demonstrating effective team and change leadership.
Ability to deal with ambiguity/uncertainty, dynamic environment and willingness to try new/challenging solutions.
Proven ability to work hands-on in a fast-paced environment.
Strong interpersonal, teamwork, and management skills.
Experience and Education Requirements:
Typically requires a Bachelor's degree with 13+ years of industry experience.
5-8 years of previous people management experience.
Travel Required:
None
Functional/Business Knowledge:
Knowledge and awareness spans all aspects of the specific functional area.
Enhances understanding and knowledge of how functional objectives support corporate objectives.
Possesses in‐depth knowledge of leading best practices in area of expertise.
Scope:
Establishes operational objectives and work plans, and delegates assignments to team members / supporting employees.
Provides guidance and support to team members / employees.
Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.
Requires the ability to effectively influence others and manage sensitive situations.
Judgement:
Works on issues where analysis of situations or data requires an in‐depth knowledge of organizational objectives.
Erroneous decisions or failure to achieve results will add to costs and may impact the short‐term goals of the organization.
Management:
Manages activities of two or more sections or departments.
Directly manages the coordination of the activities within a function/department with responsibility for results.
In some instances may be responsible for a functional area or contracted / outsourced employees or matrixed reports and not have any direct reports within the organization.
People management responsibilities include hiring / terminations, performance reviews, career development coaching and compensation decisions.
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An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Talent Acquisition at talentacquisition@dexcom.com.
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.
