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Staff Quality Assurance Engineer
2 months ago
Dexcom, Inc. is a leading developer and marketer of 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 committed to transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes.
Dexcom has a strong focus on delivering solutions that are best in class, while empowering the community to take control of diabetes.
The company has experienced significant growth, with full-year 2022 revenues of $2.9B, a growth of 18% over 2021.
Job SummaryThis position may be responsible for various aspects of Quality Engineering, including supervision of support personnel and/or administration of specific aspects of the quality system.
Job tasks require interfacing with all functions, including Operations, Quality Assurance, Engineering, Regulatory Affairs, Clinical Affairs, Biometrics, Marketing, Legal, Finance, Sales, Customer Operations, Human Resources, and upper levels of management.
Key Responsibilities- Design and Implement Quality Assurance Protocols: Design, implement, and maintain quality assurance protocols and methods for processing materials into partially finished or finished products.
- Compliance Management: 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.
- Process Improvement: Takes the initiative to develop systems and processes that improve product safety, increase product consistency and conformance to requirements, improve production efficiency, and reduce operating and scrap costs.
- Inspection and Testing: Designs methods and procedures for inspecting, testing, and evaluating the precision and accuracy of production processes, production equipment, and finished products.
- Analysis and Reporting: Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
- Technical Documentation: Responsible for reviewing, authoring, and revising appropriate technical documentation, including design history file, standard operating procedures, protocols, reports, etc.
- Compliance Assurance: May assure compliance to in-house and/or external specifications and standards, including GLP, GMP, ISO Six Sigma.
- Quality System Administration: May supervise and administer specific aspects of the quality system.
- Policy Development: Designs and applies company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations.
- Auditing and Validation: Leads or participates in internal audits, supplier audits to ensure systems comply with requirements and are effective.
- Design Team Participation: Participates as a member of the design team, assisting with defining design inputs, designing components and processes, verifying that design outputs satisfy design inputs.
- Equipment and Process Validation: Designs and performs Equipment, Process, Software, and Test Method Validations.
- Technical Guidance: Provides technical guidance with respect to equipment, software, product, and process requirements, including defining and identifying failure mode effects and analysis (FMEA).
- Risk Management: Applies risk management, validation, sample size, and external standards review and implementation activities.
- Nonconforming Materials: Assists with investigation and disposition of nonconforming materials with the Materials Review Board.
- Inspection and Review: Reads, writes, and understands specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools.
- Computer Skills: Applies proficient computer skills in the use of Microsoft Office and database applications, including Excel and MiniTab.
- Supervisory Responsibilities: Assumes and performs other duties as assigned, including supervising a small group of individuals (Technicians and Inspectors).
Bachelor's degree and minimum 7 years of related experience; or a Master's degree with minimum 5 years of related experience; or a PhD with 2 years of related experience; or equivalent combination of education and experience. Medical Device experience preferred.
