Senior QA Engineer Supplier Quality
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Job Summary
The Company
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later having pioneered an industry. And were just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized actionable insights aimed at solving important health challenges. To continue what weve started: Improving human health.
We are driven by thousands of ambitious passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening serving with integrity thinking big and being dependable. Weve already changed millions of lives and were ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. Well get there by constantly reinventing unique biosensing-technology experiences. Though weve come a long way from our small company days our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.
Meet the team:
The Senior level Supplier Quality Engineer engages suppliers in three fundamental means:
- Supplier evaluation to drive supplier assessments to determine the suppliers abilities to meet Dexcom requirements.
- Material qualification to drive qualification of components and conformance to requirements.
- Supplier development to improve capabilities of key suppliers and/or materials.
Where you come in:
- You have approval and qualification of new components and assemblies at suppliers. Qualification includes process validations consisting of IQ OQ and PQ.
- You can assess quality performance issues of suppliers using multiple input data streams from Dexcom and the suppliers process to drive / support supplier development activities.
- You are responsible for non-conformance investigations of supplier issues evaluating and approving corrective actions and performing verification of effectiveness.
- You take the initiative to develop systems and processes that: improve product safety; increase product consistency and conformance to requirements; maintain the supplier quality system improve production efficiency; reduce operating and scrap costs.
- You work cross-functionally to track and trend supplier improvements and ongoing projects.
- You 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 & ISO 14971.
- You effectively utilizes knowledge of techniques such as: six sigma methodologies gauge R&R studies process capability (Cpk/Ppk) lean manufacturing sampling plans and statistics.
What makes you successful:
- You have Strong background in any of the following processes:
- Injection molding Extrusion Stamping Electronics (PCB and PCBA manufacturing) Wire manufacturing Machining and Assembly.
- You have excellent communications and collaboration skills with internal and external teams including quality engineering manufacturing receiving inspection and supplier representatives.
- You have the ability to manage work and shifting priorities in a fast-paced manufacturing environment.
- You have previous medical device experience in quality engineering or supplier quality.
- You are able to travel as needed domestically and internationally.
- You have previous training and/or certification for quality audits.
What youll get:
- A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
- A full and comprehensive benefits program.
- Growth opportunities on a global scale.
- Access to career development through in-house learning programs and/or qualified tuition reimbursement.
- An exciting and innovative industry-leading organization committed to our employees customers and the communities we serve.
Travel Required:
- 25 to 50%
Experience and Education Requirements:
Typically requires a bachelors degree in a technical discipline and a minimum of 5-8 years related experience or masters degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience
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. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
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. Dexcoms AAP may be viewed upon request by contacting Talent Acquisition at
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
Meritain an Aetna Company creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files please click on the URL provided: 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.
Salary:
$87000.00 - $145000.00Required Experience:
Senior IC
About Company
Dexcom Continuous Glucose Monitoring is simplifying diabetes management with a small device, accurate real-time glucose readings, and proven results. No fingersticks or scanning.†
