Sr Quality Engineer I - Manufacturing

Tandem Diabetes Care Inc.; California; On-site; USD 120,000 - 170,000; Full time

Job summary

Tandem Diabetes Care Inc. seeks a Senior Quality Engineer to provide quality guidance across product launches, sustaining engineering, and quality systems in a manufacturing environment.

You will optimize internal operations, ensure conformance to specifications, and drive risk reduction throughout the hardware development lifecycle. As a quality lead, you’ll review design changes for regulatory compliance, analyze quality data, lead audits, and support CAPA investigations, NCRs, and Gage R&R,

Qualifications

• Bachelor’s degree in a technical field or equivalent work experience.
• 5+ years as a Quality Engineer in FDA-regulated hardware/medical device development.
• Solid knowledge of QMS standards: ISO 13485, FDA QMSR, ISO 14971.
• Experience querying, navigating and analyzing datasets with test/quality equipment.
• Strong statistics skills: sampling, capability analysis, SPC.
• Experience generating/analyzing quality metrics.
• Familiarity with problem-solving methods (why-why, fault tree, cause-and-effect).
• Ability to work independently to identify issues and propose fixes.
• GD&T understanding of mechanical drawings and specifications.

Responsibilities

• Lead sustaining engineering, production, and quality system activities as quality lead.
• Review/approve product and process changes ensuring V&V per regulatory requirements.
• Identify quality risks, drive actions to optimize quality and cost efficiency.
• Analyze quality problems in products and processes and implement improvements.
• Support IQ/OQ/PQ development for processes and equipment.
• Manage NCRs and monitor closures; review COs and provide quality input.
• Contribute to supplier and process improvement initiatives.

Skills

Quality engineering

Statistical methods

Problem solving

Independent work

GD&T

Quality metrics

Data analysis

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Education

Bachelor’s degree in a technical field

Job description

GROW WITH US:

Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We’d love for you to team up with us to “innovate every day,” put “people first,” and take the “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry.

STAY AWESOME:

Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology — an advanced predictive algorithm that automates insulin delivery. But we’re so much more than that. Our company’s human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Because many of our own team members live with diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at tandemdiabetes.com

A DAY IN THE LIFE:

An experienced team member in a manufacturing environment providing quality guidance and support for product launches, sustaining engineering, and quality system activities to assure conformance to established specifications and risk reduction. Works independently to optimize and continuously improve internal operations to meet department, business unit and company objectives. Also provides expertise and guidance to ensure quality systems are in place across the hardware development organization that improves quality of our devices as well as our business operations.

The Senior Quality Engineers at Tandem are also responsible for: Serves as a Quality lead on sustaining engineering, production, and quality system activities.
Reviews and approves product and process changes/new designs to ensure they are developed, verified, validated and documented in accordance with regulatory requirements.
Assures all actions required to optimize the quality, manage the risk, and maintain the compliance of all products, planned and completed, and that the results drive quality and quality system actions.
Analyzes and solves quality related problems with products and processes.
Provides input to IQ/OQ/PQ development for processes and equipment.
Supports the non-conforming material report (NCR) process and lead monitoring and tracking for open NCRs and ensure timely closures.
Reviews and approves CO’s as well as provides quality input.
Provides quality input to Complaint, First Article, CAPA investigations.
Independently completes activities in Risk Analysis, Process Capability Analysis (Cpk),, Design Reviews, Gage R&R, DOEs, V&V Testing, and reliability testing activities.
Facilitates or participates in cross-functional or cross-divisional process improvement teams to drive product development quality excellence and cost savings initiatives.
Reviews and analyzes project and customer requirements, and assists project teams in tailoring and using company procedures, methods, templates and tools.
Collects process metrics and lessons learned, reviews and evaluates processes and work products and recommends improvements as appropriate.
Supports and leads, internal and external audits as scheduled to build the quality system and reduce risk.
Confirms completion of required training plan before assuming job responsibilities.
Ensures work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements.
Other responsibilities as assigned.

WHEN & WHERE YOU’LL WORK:

This role is on-site five days a week at our Barnes Canyon office due to the nature of the work involved.

WHAT YOU’LL NEED:

• Bachelor’s degree in a technical field, preferably Mechanical Engineering or the equivalent education and applicable work experience.
• 5 plus years experience working as a Quality Engineer in an FDA-regulated hardware development environment, medical device development, or an FDA-regulated industry.
• Demonstrates proficient knowledge of Quality Engineering policies, principles and best practices.
• Proficient knowledge of quality standards (ISO 13485, FDA QMSR, ISO 14971).
• Proficiency with querying, navigating, and analyzing datasets Understands the use of all test and quality measurement equipment.
• Strong proficiency of statistical techniques including sampling theory, probability, capability analysis, and SPC.
• Previous experience generating and analyzing quality metrics.
• Demonstrated experience using problem solving methodologies: why-why analysis, fault tree analysis, cause and effect diagram etc.
• Ability to work independently to identify potential quality issues and propose solutions.
• Basic understanding of mechanical drawings & specifications including geometric dimensioning and tolerances (GD&T).
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