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Sr. Engineer, Supplier Quality Engineering

extra holidays - extra parental leave
Remote: 
Full Remote
Contract: 
Experience: 
Senior (5-10 years)
Work from: 

Offer summary

Qualifications:

Bachelor's degree in a technical discipline with 5-8 years of related experience, or Master's degree with 2-5 years, or a PhD with 0-2 years experience, Experience in stamping, grinding, and electro-polishing (sheet metal processes), Knowledge of 21CFR Part 820 and ISO 13485 quality systems regulations, DFMEA, and PFMEA, Certification or training in quality audits is highly desired.

Key responsabilities:

  • Design and maintain the supplier quality management system and provide guidance to other departments
  • Conduct supplier qualification audits, monitor performance, manage corrective actions, and maintain compliance
  • Serve as Chairperson on the Supplier Review Committee, lead supplier audits, assist in design team activities
  • Develop systems to improve product safety, consistency, conformance, production efficiency, and cost reduction
Dexcom logo
Dexcom XLarge https://careers.dexcom.com/
5001 - 10000 Employees
See more Dexcom offers

Job description

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 full-year 2022 revenues of $2.9B, a growth of 18% over 2021. Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 8,000 people worldwide.

Summary: 

The incumbent is responsible for performing all the duties of a Senior Supplier Quality Engineer. Performs tasks with greater scope and minimal oversight from the Supervisor. May assist or supervise other Quality Engineers, technicians and/or administrative personnel in the performance of their duties. May also supervise and administer specific aspects of the quality system. The incumbent will be systematic, highly organized and articulate, and work in a team environment. Job tasks require interfacing with external suppliers and internal manufacturing, engineering, regulatory, quality, and materials personnel, and senior management. A positive attitude is important while working in a fast-paced manufacturing environment and dealing with shifting priorities. 

                                    

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 manage the supplier corrective action system. 

  • Ability to frequently travel in the U.S. and internationally. 

  • Serves as the Chairperson on the Supplier Review Committee (SRC) and ensures ongoing supplier program transparency and open communication between cross-functional departments. 

  • Establishes and maintains the Supplier Audit Schedule and ensures compliance with this schedule. 

  • Serves as the supplier quality representative during internal audits and for designated suppliers, as necessary.  

  • 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.), as defined in the Quality Agreement.  

  • 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. 

  • Have knowledge of techniques like six sigma, lean manufacturing, sampling plans and statistics. 

  • 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. 

  • Works and communicates effectively and professionally 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 knowledge of the Quality Systems Regulations 21CFR Part 820 and international quality systems and medical device standards (e.g. ISO 13485). 

  • Certified or trained to perform quality audits is highly desired. 

  • Assumes and performs other duties as assigned. 

 

Experience and Education Requirements: 

  • Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 5-8 years related experience or Master’s degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience. 

  • Stamping, grinding, electro-polishing (sheet metal processes) experience 

 

Travel Required: 

  • 0 – 24% 

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.

Required profile

Experience

Level of experience: Senior (5-10 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Verbal Communication Skills
  • Organizational Skills
  • Self-Motivation
  • Teamwork
  • Microsoft Office

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