Sr Quality Engineer I - Manufacturing

Tandem Diabetes; California; On-site; USD 110,000 - 170,000; Full time

Job summary

Tandem Diabetes Care is hiring a Senior Quality Engineer to lead sustaining engineering, quality systems, and process improvements for our hardware development programs. This role will ensure product and process changes meet regulatory requirements while driving risk reduction and quality excellence across the organization.

You will support audits, NCRs, CAPAs, and cross-functional teams; work on-site five days a week at the Barnes Canyon office, adhering to Privacy/HIPAA and safety standards.

Qualifications

• Bachelor’s degree in a technical field, preferably Mechanical Engineering
• 5+ years experience as a Quality Engineer in an FDA-regulated hardware development environment, medical device development, or FDA-regulated industry.
• Proficient knowledge of Quality Engineering policies and best practices.
• Proficient knowledge of ISO 13485, FDA QMSR, ISO 14971.
• Proficiency with querying, analyzing datasets and quality measurement equipment.
• Strong statistics including sampling theory, probability, capability analysis, and SPC.
• Experience using problem solving methodologies (why-why, fault tree, cause-effect).
• Ability to work independently to identify issues and propose solutions.
• Understanding of GD&T and mechanical drawings.

Responsibilities

• Lead sustaining engineering, production, and quality system activities.
• Review and approve product and process changes/new designs per regulatory requirements.
• Analyze and solve quality problems with products and processes.
• Provide input to IQ/OQ/PQ development for processes and equipment.
• Support NCR process and monitor closures; ensure timely resolution.
• Lead cross-functional process improvement teams to drive quality and cost savings.
• Ensure training completion before assuming responsibilities.
• Ensure compliance with Privacy/HIPAA, safety, and company policies.

Skills

Quality engineering

Statistical analysis

Problem solving

Independent worker

Data analysis

Quality metrics

GD&T understanding

Communication

Education

Bachelor’s degree in a technical field

Tools

IQ/OQ/PQ development

Gage R&R

Design of Experiments (DoE)

V&V testing

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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