Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM)
systems. Headquartered in San Diego, California, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom simplifies and improves diabetes management around the world.Summary
The Senior 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.
Job activities are traceable back to these means through the following Essential Duties and Responsibilities.Functional Description
: Technical Individual Contributors
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).Essential Duties and Responsibilities:
- Maintain the supplier quality management system according to written policies and procedures. Will provide key input on compliance and continuous improvement of business processes.
- Provide quality guidance to other departments.
- Perform supplier qualification audits, monitor supplier performance, provide information for supplier program metrics and periodic reports, and assist in management of the supplier corrective action system.
- Maintains the Supplier Audit Schedule and ensures compliance with this schedule.
- May attend and support internal audits by regulatory and other outside agencies.
- Establishes and maintains supplier Quality Agreements, where needed, and any joint periodic supplier business reviews. Reviews and approves supplier documentation (protocols, reports, specifications, etc.), as defined in the Quality Agreements.
- May work 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 a working knowledge of techniques like six sigma, lean manufacturing, sampling plans and statistics.
- Provides training and guidance to lower level quality engineers and new hires.
- Takes the initiative to improve systems and processes that: increase product safety; increase product consistency and conformance to requirements; improve production efficiency and communication; reduce operating and scrap costs.
- Reads, writes, and understands specifications and inspection criteria.
- Reads schematics and mechanical drawings and provides input into revisions, as needed.
- 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.
- 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 as needed
- Travels as needed within in the U.S. and internationally.
- Assumes and performs other duties as assigned.
- 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.
Experience and Education Requirements:
- Possess manufacturing experience in the following processes:
- Injection molding
- Electronics (PCB and PCBA manufacturing)
- Wire manufacturing
- 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 good 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:Functional/Business Knowledge:
- 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.
- Possesses broad understanding of technical principles and theories. Ability to synthesize external data and research findings for application that may impact technical objectives.
- Demonstrates successes in technical proficiency and independent thought. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Exercises good judgment in selecting methods and techniques for obtaining solutions.
- Normally receives little instruction on day-to-day work, general instructions on new assignments.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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 Talent Acquisition at email@example.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.