Director of Quality Engineering
4 days ago
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.
- Reviews documents on Change Orders to ensure that the Quality System remains in compliance with all applicable laws and standards.
- Confirms completion of required training plans before assigning job responsibilities.
- Supports the short and long-term planning for the department including headcount, budgeting, training, and systems requirements.
- Participates in the selection, development, performance appraisal, merit recommendation, and promotion of staff.
- Ensures department staff is properly trained, per designated training plan, before assuming job responsibilities.
- Develops and manages schedules and performance requirements of staff.
- Confirms completion of required training plans before assigning job responsibilities.
- Ensures work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements.
- Develops and properly manages department budget.
- 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.
- Lean manufacturing and Six Sigma experience desirable.
- Certified Quality Engineer, Six Sigma Blackbelt, Quality Auditor, Reliability Engineer, or equivalent desired.
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 such as 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.
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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