Senior QA Engineer

Dexcom • San Diego, CA

2d

About The Position

Injection molding Electronics (PCB and PCBA manufacturing) Battery Assembly 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. 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. 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. Reads, writes, and understands specifications and inspection criteria. Reads schematics and mechanical drawings and provides input into revisions, as needed. Has understanding of Design and Process Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA). Possesses knowledge of techniques like six sigma, Gage R&D studies, process capability measurement tools (Cpk), lean manufacturing, sampling plans and statistics. 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. Conducts failure investigations as needed Maintain the supplier quality management system according to written policies and procedures. Will provide key input on compliance and continuous improvement of business processes. Works cross-functionally to track and trend supplier improvements. Works and communicates effectively and professionally in a team environment with minimal supervision. Assumes and performs other duties as assigned. Ability to manage shifting priorities with minimal difficulties. Provides training and guidance to lower level quality engineers and new hires. Applies proficient computer skills in the use of Microsoft Office and database applications. Performs process evaluation of key processes of assigned suppliers to drive / support supplier development activities. 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. 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.

Requirements

• Knowledge of the Quality Systems Regulations 21CFR Part 820 and international quality systems and medical device standards (e.g. ISO 13485)
• Understanding of Design and Process Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA)
• Knowledge of techniques like six sigma, Gage R&D studies, process capability measurement tools (Cpk), lean manufacturing, sampling plans and statistics
• Ability to manage shifting priorities with minimal difficulties
• Proficient computer skills in the use of Microsoft Office and database applications
• 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

Nice To Haves

• Certified or trained to perform quality audits is highly desired

Responsibilities

• Perform supplier qualification audits
• Monitor supplier performance
• Provide information for supplier program metrics and periodic reports
• Assist in management of the supplier corrective action system
• Maintain the Supplier Audit Schedule and ensures compliance with this schedule
• Attend and support internal audits by regulatory and other outside agencies
• Establish and maintain supplier Quality Agreements, where needed, and any joint periodic supplier business reviews
• Review and approve supplier documentation (protocols, reports, specifications, etc.), as defined in the Quality Agreements
• Work as a member of the design team, as required
• Assist with defining design inputs
• Design components and processes
• Verify that design outputs satisfy design inputs
• Read, write, and understand specifications and inspection criteria
• Read schematics and mechanical drawings and provides input into revisions, as needed
• Conduct failure investigations as needed
• Maintain the supplier quality management system according to written policies and procedures
• Provide key input on compliance and continuous improvement of business processes
• Work cross-functionally to track and trend supplier improvements
• Work and communicate effectively and professionally in a team environment with minimal supervision
• Assume and perform other duties as assigned
• Provide training and guidance to lower level quality engineers and new hires
• Apply proficient computer skills in the use of Microsoft Office and database applications
• Perform process evaluation of key processes of assigned suppliers to drive / support supplier development activities

What This Job Offers

• Career Level: Mid Level