Director of Quality Engineering

2 weeks ago

San Diego, California, United States Tandem Full time
About the Role

We are seeking a highly skilled and experienced Quality Engineering Director to join our team at Tandem. As a key member of our R&D organization, you will be responsible for ensuring the quality and compliance of all products developed by the company.

Key Responsibilities
  • Manage the quality system requirements and provide design quality and quality engineering support for the product development process.
  • Lead cross-functional teams to determine quality system requirements and provide design quality and quality engineering support for the product development process.
  • Drive functional excellence in design quality by coaching and mentoring on product design control and development best practices.
  • Provide critical quality engineering direction to projects concerning generally accepted quality engineering tools and principles.
  • Develop and implement strategies to improve product and development project performance.
  • Work cross-functionally to evaluate new projects, assign quality resources, and ensure resourcing aligns with company priorities.
  • Drive and evaluate project and department progress, technical development plans, and results.
  • Responsible for driving strategic decision-making based on quality strategy, identifying, and addressing areas of risk.
  • Hire, train, lead, and develop Quality Design Engineering professionals to improve department effectiveness and productivity.
  • Maintain expertise in current and emerging GMP, QSR, Sterilization, regulatory compliance standards.
  • Act as Tandem representative in FDA and other regulatory inspections.
  • Work closely with the Regulatory team to complete FDA submissions.
  • Assist in the review and approval of new products and design changes to ensure they are developed, verified, validated, and documented in accordance with internal and regulatory requirements.
  • Lead the risk analysis and disposition of software anomalies and verification and validation failures.
  • Provide quality input and support to Complaint, FI, CAPA, NCR investigations.
  • Lead Risk Analysis activities, Design Reviews, Test Method Validation, DOEs, and Verification and Validation Testing.
  • Review documents on Change Orders to ensure the Quality System remains in compliance with all applicable laws and standards.
  • Confirm completion of required training plans before assigning job responsibilities.
  • Support the short and long-term planning for the department, including headcount, budgeting, training, and systems requirements.
  • Participate in the selection, development, performance appraisal, merit recommendation, and promotion of staff.
  • Ensure department staff is properly trained, per designated training plan, before assuming job responsibilities.
  • Develop and manage schedules and performance requirements of staff.
  • Confirm completion of required training plans before assigning job responsibilities.
  • Ensure work is performed in compliance with company policies, including Privacy/HIPAA and other regulatory, legal, and safety requirements.
  • Develop and properly manage department budget.
Requirements
  • 12 years of related experience in the field, including 8 years of Quality Engineering experience.
  • Experience releasing products in a regulated environment.
  • Proven ability to lead teams and obtain targeted results.
  • Prior experience leading/supervising a customer-facing department and associated staff is required.
  • 7 years previous management experience.
  • Experience in hardware, software development, and digital platform products.
  • Bachelor's degree in engineering, or equivalent combination of education and applicable job experience.
  • Proficient knowledge of regulations and standards: ISO 9001, ISO 13485, IEC 62304, ISO 11137, 21CFR Part 820, and other appropriate industry standards.
  • Familiarity with an object-oriented programming language.
  • Strong knowledge and application of principles of Good Manufacturing Processes (GMP).
  • Strong technical contributor and leader in the Quality Engineering organization.
Preferred Qualifications
  • Lean manufacturing and Six Sigma experience desirable.
  • Certified Quality Engineer, Six Sigma Blackbelt, Quality Auditor, Reliability Engineer, or equivalent desired.
About Tandem

Tandem is a company that creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We are proud to manufacture and sell the t:slim X2 insulin pump with Control-IQ technology.

What We Offer
  • A competitive compensation package that includes bonus, equity, and a robust benefits package.
  • Health care benefits, including medical, dental, vision, health savings accounts, and flexible saving accounts.
  • 11 paid holidays per year, a minimum of 20 days of paid time off (starting in year 1), and access to a 401k plan with company match.
Equal Opportunity Employer

Tandem is firmly committed to being an equal opportunity employer and maintaining a diverse and inclusive environment. We value and embrace that every single one of us brings value to the table.

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