Staff QA Engineer at Dexcom (San Diego, CA)

| San Diego, CA
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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.

Summary:

The Staff level Supplier Quality Engineer engages suppliers in three fundamental means:
  • Supplier evaluation to drive supplier assessments to determine supplier abilities to meet Dexcom requirements.
  • Material qualification to drive material assessments to determine conformance to requirements.
  • Supplier development to improve capabilities of key suppliers and/or materials.

Essential Duties and Responsibilities:
  • Design and maintain the supplier quality management system according to written policies and procedures.
  • Provide quality guidance to other departments.
  • Perform supplier qualification audits, monitor supplier performance, provide supplier program metrics and periodic reports, and administer the supplier corrective action system.
  • Works with team to establish and maintain the Supplier Audit Schedule and ensures compliance with this schedule.
  • May serve as the supplier quality representative during internal audits and for designated suppliers.
  • Ensures Quality Agreements are established, where needed, and that any joint periodic business reviews are conducted.
  • Reviews and approves supplier documentation (protocols, reports, specifications, etc.).
  • Works as a member of the design team, as required. Some type of activities may include assisting with defining design inputs; designing components and processes; verifying that design outputs satisfy design inputs.
  • Takes the initiative to develop systems and processes that: improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs.
  • Reads, writes, and understands specifications and inspection criteria.
  • Reads schematics and mechanical drawings.
  • Communicates effectively and collaborates well in a team environment with minimal supervision.
  • Applies proficient computer skills in the use of Microsoft Office and database applications (such as Oracle, Agile and MiniTab).
  • Has understanding of Design and Process Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA).
  • Possess an in-depth and professional level of knowledge of the Quality Systems Regulations 21CFR Part 820 and international quality systems and medical device standards including ISO 13485.
  • Certified (i.e., Possesses an ASQ CQA Certificate) or otherwise professionally trained to perform quality system audits with a minimum of 4 years of hands-on experience in conducting and leading quality systems audits and supplier qualifications in the medical device industry.
  • Experience with supplier quality systems development is highly desired.
  • Possesses knowledge of techniques like six sigma, Gage R&D studies, process capability measurement tools (Cpk), lean manufacturing, sampling plans and statistics.
  • Assesses quality performance issues of assigned suppliers using multiple input data streams from Dexcom and the supplier's process to drive / support supplier development activities.
  • Performs process evaluation of key processes of assigned suppliers to drive / support supplier development activities.
  • Works cross-functionally to track and trend supplier improvements.
  • Conducts failure investigations
  • Travels as needed within in the U.S. and internationally.
  • Assumes and performs other duties as assigned.

Required Qualifications:
  • Must be able to perform 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.
  • 5 years related experience and/or training, or equivalent combination of education and experience.

Preferred Qualifications:
  • Possess manufacturing experience in the following processes:
    • Injection molding
    • Extrusion
    • Stamping
    • Electronics (PCB and PCBA manufacturing)
    • Wire manufacturing
    • Machining
    • Assembly
  • Possess continual improvement background (6 sigma, Lean Manufacturing, etc.).
  • Excellent communications and excellent collaboration, with expected internal and external interfaces. (Internal examples: Supplier Quality, Quality, Engineering, Manufacturing, Regulatory Affairs, Receiving Inspection. External examples: Suppliers).
  • Possess and exercise excellent business acumen.
  • Ability to manage work with a positive attitude while working in a fast-paced manufacturing environment.
  • Ability to manage shifting priorities with minimal difficulties.
  • Previous medical device experience.
  • Previous supplier quality engineering or quality engineering experience.

Travel Required:
  • 25-50%

#LI-AP1

Functional Description

Designs, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products. Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution. Designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products. Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary. May assure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma).

Functional/Business Knowledge

  • Possesses advanced knowledge of technical principles and theories. Recommends solutions in support of functional objectives tied to overall company objectives and strategies.

Scope

  • Demonstrates significant technical expertise, collaboration with others and independent thought. Anticipates potential complex problems requiring an in-depth evaluation. Demonstrates strategic thinking and commercial/industry understanding in functional projects.

Judgement

  • Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
  • Determines methods and procedures on new assignments and may coordinate activities of other colleagues.

Management

  • N/A

Field Sales

  • N/A

Experience and Education

  • Typically requires a Bachelors degree in a technical discipline, and a minimum of 8-12 years related experience or Masters degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of 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.

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 [email protected]

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 protected]

View the OFCCP's Pay Transparency Non Discrimination Provision at this link.
More Information on Dexcom
Dexcom operates in the Biotech industry. The company is located in San Diego, CA, Mesa, AZ, Portland, OR and Dania Beach, FL. Dexcom was founded in 1999. It has 3973 total employees. It offers perks and benefits such as Flexible Spending Account (FSA), Disability Insurance, Dental Benefits, Vision Benefits, Health Insurance Benefits and Life Insurance. To see all 60 open jobs at Dexcom, click here.
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