Manager Quality Assurance

About Dexcom
Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. Since the company’s inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class - while empowering the community to take control of diabetes. Dexcom reported expected full-year 2021 revenues of $2.48B, a growth of 27% over 2020. Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 6,000 people worldwide.
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*Summary: *
Manages the development and implementation of the organization’s quality policies and programs. Manages and mentors Quality Assurance staff. Assures systems are in compliance with ISO and FDA quality system regulations.
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*Essential Duties and Responsibilities: *

• Manages Quality Assurance Team (Quality Assurance, Quality Control, QA Engineering). Defines priorities and delegates responsibilities.
• Coordinates, manages and tracks the QA team’s efforts, ensuring milestones are met within defined budgets and schedules.
• Designs and applies company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations. Some examples include Equipment, Process, Software and Test Method Validation, Auditing, Calibrations, CAPA, Customer complaint processing,
• Document control, Nonconforming materials, Process controls, Receiving inspection, Training.
• Applies risk management, equipment and process validation, sample size, and external standards review and implementation activities
• Documents and reports quality findings to senior and executive management, project/program managers, development team. Follow-up on ongoing issues. Provides coaching and guidance on format, content and quality of project plans, requirements, design, and test cases.
• Manages, leads, improves, and maintains quality methodologies, processes, and procedures.
• Establishes and implements quality specifications, standards and programs for supplies/components, finished products and/or the packaging thereof.
• Develops master plan timetable for quality initiatives.
• Develops and monitors key metrics to assess the quality of products, supplies, inspection and testing systems.
• Manages and coordinates inspection, sampling, testing, and/or packaging of supplies/components and finished products.
• Utilizes quality feedback data from customers and consumers to drive continual improvement activities needed to achieve department strategic goals.
• Reviews data on product defects, product response plans and product dispositions; recommends and implements improvements.
• Assists research and development, engineering, etc., in formulating new products or in establishing standards for these products prior to initial production.
• Compiles statistical data and writes narrative reports summarizing quality findings.
• Oversees personnel engaged in quality control/assurance.
• Develops and implements a successful vision/strategy, through strong leadership skills.
• Develops or approves recommendations to change systems, policies, and procedures; ensures timely and accurate implementation.
• Participates in department and inter-department planning and management teams and works cross-functionally to improve processes within the organization.
• Develops and maintains operating budget and capital spending plan.
• Plans manpower requirements.
• Identifies and obtains staff capabilities needed to accomplish objectives.
• Monitors and ensures achievement of performance goals and objectives either directly or through subordinate staff.
• Oversees and handles projects that have short to long-term focus.
• Balances planning efforts with day-to-day demands.
• Responsible for ensuring that department understands and complies with quality standards and requirements as documented.
• Responsible for understanding and complying with applicable quality, environmental and safety regulatory considerations. Responsible in assuring compliance to FDA QSR regulations.
• Ensures employee conformance to established best practices and proper training of staff.
• This job description reflects management’s assignment of essential functions; it does not prescribe or restrict the tasks that may be assigned.

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*Required Qualifications: *

• 5 years of related experience and/or training; or equivalent combination of education and experience.

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*Education Requirements: *

• Bachelor's degree from four-year college or university preferred.

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*Travel Required: *

• 0 – 24%

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*Supervisory Responsibilities: *
Directly supervises employees. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Is responsible for the overall direction, coordination, and evaluation of this area. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
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*Language Skills: *Must be able to communicate effectively in English. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
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*Physical Demands: *The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. May be required to perform the following Physical Activity: Standing, walking, sitting, using hands, handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch, or crawl, talk or hear, taste or smell. May be required to lift 0 lbs. to over 100 lbs.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. May be exposed to the following environmental conditions: Wet or humid conditions, work near moving parts, work in high - precarious places, fumes or airborne particles, toxic or caustic chemicals, outdoor weather conditions, extreme heat (non-weather), extreme cold (non-weather), risk of electric shock, work with explosives, risk of radiation, vibration. The noise level in this work environment can range from quiet to very loud.
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*Functional Description*
Directs the design, development, modification and evaluation of a technical infrastructure to expedite the operation and evaluation of clinical trials. Manages the design, monitors the statistical analysis and develops tracking systems to determine the efficiency of clinical trials. Manages the evaluation and design of clinical data statistics. Must have expertise in state–of–the–art data manipulation and statistical analyses. Selects, develops and evaluates personnel to ensure the efficient operation of the function.
Functional/Business Knowledge

• Knowledge and awareness spans all aspects of the specific functional area.
• Having wide-ranging experience, uses professional concepts and knowledge of company objectives to resolve complex issues in creative and effective ways.
• Develops a proficiency of the company's business / market in order to inform decisions.

Scope

• Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals.
• Provides guidance to team members / supporting employees using established company policies.
• Frequently interacts with subordinate supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company.

Judgement

• Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors.
• Follows processes and policies in selecting methods and techniques for obtaining solutions.
• Erroneous decisions or failure to achieve results will add to costs and may impact the short-term goals of the organization.

Management

• Manages the coordination of department/functional activities with responsibility for results, methods and staffing.
• In some instances may be responsible for a functional area or contracted / outsourced employees or matrixed reports.
• People management responsibilities include hiring / terminations, performance reviews, career development coaching and compensation decisions.

Field Sales

• N/A

Experience and Education

• Typically requires a Bachelors degree with 8-12 years of industry experience.
• 2-5 years of previous management or lead experience.

Workplace Type

• The Workplace Type for this role is Assigned Desk. Based on the nature of your role you will have an assigned desk or office located at a Dexcom site and should plan to be onsite approximately 4-5 days per week.

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_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 Dexcom Talent Acquisition at _talentacquisition@dexcom.com.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at talentacquisition@dexcom.com.
View the OFCCP's Pay Transparency Non Discrimination Provision at this link.

Job Type: Full-time

Pay: $110,000.00 - $125,000.00 per year