Sr Quality Engineer I - Manufacturing

Tandem Diabetes Care•San Diego, CA

7d•$110,000 - $121,000•Onsite

About The Position

Tandem Diabetes Care is hiring an experienced Quality Engineer to provide quality guidance and support in a manufacturing environment. The role supports product launches, sustaining engineering, production, and quality system activities to ensure products conform to specifications and risks are reduced. The engineer works independently to optimize and continuously improve operations and provides expertise to help ensure quality systems support hardware development and improve device quality and business operations. The position is on-site five days per week at Tandem’s Barnes Canyon office. The starting base pay range is $110,000–$121,000 annually. Tandem also offers a competitive compensation package that includes a bonus and a robust benefits package.

Requirements

Bachelor’s degree in a technical field, preferably Mechanical Engineering, or equivalent education and applicable work experience.
More than five years of experience as a Quality Engineer in an FDA-regulated hardware development environment, medical device development, or another FDA-regulated industry.
Proficient knowledge of Quality Engineering policies, principles, and best practices.
Proficient knowledge of quality standards, including ISO 13485, FDA QMSR, and ISO 14971.
Proficiency querying, navigating, and analyzing datasets.
Understanding of the use of test and quality measurement equipment.
Strong proficiency in statistical techniques, including sampling theory, probability, capability analysis, and SPC.
Experience generating and analyzing quality metrics.
Demonstrated experience with problem-solving methodologies such as why-why analysis, fault tree analysis, and cause-and-effect diagrams.
Ability to work independently to identify potential quality issues and propose solutions.
Basic understanding of mechanical drawings and specifications, including geometric dimensioning and tolerancing (GD&T).
Ability to recognize non-conformances against accepted and documented practices.
Ability to assert ideas and persuade others by consolidating, evaluating, and presenting relevant information effectively.
Skill in promoting team cooperation and commitment to team success.
Ability to view change as an opportunity to improve business performance and advocate for change when necessary.
Ability to use Microsoft Office applications, including Word, Excel, and Outlook, as well as MiniTab and other applicable software packages.
Must be authorized to work for any employer in the United States; the employer is unable to sponsor or take over sponsorship of an employment visa.

Nice To Haves

Experience in an ISO environment is preferred.

Responsibilities

Serve as a Quality lead for sustaining engineering, production, and quality system activities.
Review and approve product and process changes and new designs to ensure they are developed, verified, validated, and documented in accordance with regulatory requirements.
Ensure actions to optimize quality, manage risk, and maintain product compliance are completed, and that results drive quality and quality system actions.
Analyze and solve quality-related problems involving products and processes.
Provide input to IQ/OQ/PQ development for processes and equipment.
Support the non-conforming material report (NCR) process; lead monitoring and tracking of open NCRs and ensure timely closure.
Review and approve change orders (COs) and provide quality input.
Provide quality input to Complaint, First Article, and CAPA investigations.
Independently perform Risk Analysis, Process Capability Analysis (Cpk), Design Reviews, Gage R&R, DOEs, V&V testing, and reliability testing activities.
Facilitate or participate in cross-functional or cross-divisional process-improvement teams to advance product-development quality and cost-savings initiatives.
Review and analyze project and customer requirements, and help project teams tailor and use company procedures, methods, templates, and tools.
Collect process metrics and lessons learned; review and evaluate processes and work products; and recommend improvements as appropriate.
Support and lead scheduled internal and external audits to strengthen the quality system and reduce risk.
Confirm completion of the required training plan before assuming job responsibilities.
Ensure work complies with company policies, including Privacy/HIPAA, and applicable regulatory, legal, and safety requirements.
Perform other responsibilities as assigned.