Supervisor Quality Assurance

DexCom • San Diego, CA

4d • Onsite

About The Position

The Supervisor Quality Assurance manages a team of Quality Inspection personnel in the Receiving Inspection area in San Diego COGS department and a group of Quality Supports that coordinates and maintains material traceability of Nonconforming Material through the San Diego site. The supervisor organizes the tasks and requirements of the Receiving Inspection area in coordination with Logistics and Distribution management at Dexcom’s SD inbound Materials warehouse and coordinates the tasks and work plans of the Non-Conforming Material (NCMR) area. Controlling incoming materials for our manufacturing process is critical to maintaining our manufacturing schedules and high-quality standards in a high-paced environment, maintaining and continuously improving controls for nonconforming material is second nature to this role to deliver only the best product for our patients and customers. The team engages with planning, manufacturing, microbiology, supplier quality teams, R&D departments as part of daily interactions. It is a role with high visibility across the QA department but also across the entire organization.

Requirements

• Experience in supervision in medical device or equivalent regulated industry applying quality management systems.
• Understanding of 21CFR820 Code of Federal Regulations, and EN ISO 13485 Medical Devices – Quality management systems.
• Must have strong written and verbal communication skills.
• Strong interpersonal skills.
• A self-motivated individual, able to work in a team with minimal supervision.
• Able to read and understand drawings and specifications and inspection criteria and to apply criteria using appropriate and properly configured inspection tools.
• Understanding of acceptance sampling plans, ANSI/ASQ Z1.4, Z1.9 and C=0.
• Understanding of the Non-conforming Material control process in the medical device industry.
• Metrology systems knowledge
• GDT knowledge
• Strong computer skills desired; proficient in use of Microsoft Office and database applications.
• 5-8 years of industry experience
• Informal management/ team lead experience
• Typically requires a Bachelor’s degree with 6-8 years of industry experience
• Formal Management/team lead experience

Nice To Haves

• Oracle, 1factory, IQVIA, Reliance and SolidWorks experience preferred.
• Experience with operation of vision systems such as Keyence, OGP and Mitutoyo.
• Experience with Heigh Gages and CT scanners for metrology desirable.

Responsibilities

• Perform supervisory and administrative duties associated with Receiving Inspection and QA Support personnel.
• Coordinate tasks and work plans of the Receiving Inspection and Nonconforming Material area.
• Observes and verifies the accuracy and adequacy of the inspection activities and records, including activities in 1factory inspection system.
• Observes and verifies the accuracy and adequacy of the NCMR activities and records in IQVIA.
• Responsible for material flow, storage of parts, and accurate inventory transactions within the MRP system.
• Responsible for inventory cycle counts for Material Review Board (MRB) sub-inventory locations.
• Managing First Article Inspections and ad hoc inspection requirements through Jira.
• Maintains quality metrics and reports, as required.
• Identifies and implements continuous improvement projects.
• Writes and updates area related procedures and work instructions as necessary.
• Responsible for supporting inspection of engineering builds.
• Works across sites to ensure alignment of Receiving Inspection Activities
• Conducts training for personnel.
• Works with QA, Manufacturing, Engineering, and other department personnel, as necessary, to support quality and business objectives.
• Assumes and performs other duties as assigned.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level