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.
Incumbent is responsible for performing a variety of work functions related to in-process inspections/testing, LHR reviews, and product release. Incumbent will develop related inspection procedures, train and supervise one or more inspectors, schedule inspection activities, ensure proper documentation of inspection results, and review inspection documentation for accuracy and conformance to requirements. Prefer that incumbent is proficient with inspection of kitted and/or packaged parts, sterilized product, solutions, and electronic medical device components. Support internal quality systems, internal audits, and assist with investigations of nonconforming material, as necessary. The incumbent will be systematic, highly organized and able to articulate thoughts well. Must be able to supervise personnel and work in a cGMP regulated environment. Requires interfacing with various QA, Manufacturing, R&D, and Engineering personnel. Must be able to multi-task several shifting priorities while working in a fast-paced manufacturing environment.
Essential Duties & Responsibilities:
- Performs supervisory and administrative duties associated with Quality Department personnel.
- Ensures Quality Department personnel are properly trained and provides ongoing guidance and mentoring to direct reports on quality objectives, compliance, soft skills, leadership, technical, and other.
- Coordinates the tasks and work plans for the Quality Department personnel on shift.
- Assist with the investigation and closure of NCMR process during manufacturing of commercial and clinical product.
- Observes and verifies the accuracy and adequacy of the inspection activities and records.
- Responsible for QA material flow and accurate material related transactions within Dexcom's MRP and LHR systems.
- Generates and maintains quality metrics and reports, and implements appropriate preventive/corrective actions, (as needed) to improve quality.
- Identifies problems, and proposes solutions that are timely, cost-effective, and meet quality and business requirements.
- Assists in development of inspection/test procedures for all areas of responsibility.
- Drives continuous improvement and efficiency efforts for all Quality functions; including written procedure initiation and revisions.
- Works with Quality, Manufacturing, Engineering, and other department personnel, as necessary, to support quality and business objectives. Assumes and performs other duties as assigned.
- Monitors personnel and equipment resources against business forecasts on an ongoing basis and ensures management is updated on changing needs for the department.
- Interviews new hire candidates for both temporary and full time employee (FTE) positions. Makes decisions on candidate qualifications for hiring.
- Establishes and maintains employee performance scorecards on a monthly basis. Monitors employee performance and initiates performance improvement plans (PIP), as needed.
- To perform this job successfully, an individual must be able to execute each essential duty satisfactorily.
- The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Minimum of five years Quality, QA and/or QC supervisory experience, preferably in the areas of QA/QC inspection and product release, in a GMP regulated medical device manufacturing environment.
- Experience with managing direct and indirect personnel.
- Experience with the in-process inspection of electronic products, solutions, kitted/packaged product and engineering/R&D materials, a plus.
- Able to read and understand procedures and inspection criteria.
- A self-motivated and meticulous individual, able to work in a team with minimal supervision.
- Strong computer skills desired; proficient in use of Microsoft Office and database applications. Oracle, Agile, and Camstar experience is a plus.
- Must have strong written and verbal communication skills.
- An ASQ Certified Quality Technician (CQT) and/or an industry related Technical Certification is desirable.
Supervisory Responsibilities: Directly supervises one or more employees in the Quality department. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Language Skills: Ability to read and interpret documents such as safety rules, operating instructions, and inspection procedures. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry. Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
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. The employee frequently is required to sit and talk or hear. The employee is required to stand; walk; reach with hands and arms; climb or balance; and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color identification, and ability to adjust focus.
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. Work will be performed in both manufacturing and test lab environments. The noise level in the work environment is usually moderate.
Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons.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
- Strong knowledge of technical and functional principles and ability to teach others.
- Understands company mission and strategies.
- Receives assignments in the form of objectives with goals and the process by which to meet goals.
- Provides direction to others according to established policies and management guidance.
- Administers company policies that directly affect team members / supporting employees.
- Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
- Networks with senior internal and external colleagues in own area of expertise.
- Works on issues where analysis of situation or data requires review of relevant factors.
- Erroneous decisions or failure to achieve results will cause delays in schedules / work products.
Experience and Education
- Provides direct supervision to individual contributors and/or support individual contributors/matrix reports.
- Acts as advisor to unit or sub/units and may become actively involved, as required, to meet schedules and resolve problems.
- People management responsibilities include hiring / terminations, performance reviews, career development coaching and compensation decisions.
- Typically requires a Bachelors degree with 5-8 years of industry experience.
- Informal management/ team lead experience.
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 firstname.lastname@example.org.
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 email@example.com.
View the OFCCP's Pay Transparency Non Discrimination Provision at this link. UnitedHealthcare creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://transparency-in-coverage.uhc.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.
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