Director, R&D Quality Engineering

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 a "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 t:slim X2 insulin pump with Control-IQ technology. We're also 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. Since many of our own team members live with type 1 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: Responsible for the overall quality and compliance of all products developed by the Company. Manages the department staff to determine quality system requirements and provide design quality and quality engineering support for the product development process, including cross-functional cooperation as part of core product development teams and transfer to manufacturing.
Functions as a key business partner with R&D and product management and contributes to the overall strategic direction and success.Drive functional excellence in design quality by coaching and mentoring on product design control and development best practices via creating, using, and maintaining Risk Management file(s) throughout the product's full life cycle.Provide critical quality engineering direction to projects concerning generally accepted quality engineering tools/principles, such as product and component qualification, process validation, measurement systems analysis, test method validation, root cause analysis, risk analysis, risk mitigation, sampling, and control plans.Develop, collaborate, communicate, and implement strategies to improve product and development project performance.Work cross-functionally to evaluate new projects, assign quality resources to core teams and ensure resourcing aligns with company priorities, monitor progress, identify and resolve technical issues, and manage escalations.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.Hires, trains, leads and develops Quality Design Engineering professionals, to improve department effectiveness and productivity.Maintains expertise in current and emerging GMP, QSR, Sterilization, regulatory compliance standards, including but not limited to ISO13485, ISO 9001, IEC 62304, ISO 60601, ISO 14971, 21CFR Part 820, and international standards.Acts as Tandem representative in FDA and other regulatory inspections; provides direct interaction with officials during audits, inspections, and inquiries.Works closely with the Regulatory team to complete FDA submissions; liaising with the FDA as needed.Assists 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.Leads the risk analysis and disposition of software anomalies and verification and validation failures.Provides quality input and support to Complaint, FI, CAPA, NCR investigations; directs, supports, and executes corrective actions when applicable.Leads 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 and that the system is as efficient and effective as possible.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.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.Performs other assignments or projects as directed.YOU'RE AWESOME AT:
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.Capable of using statistical techniques: sampling theory, probability, reliability, and capability, SPC, GR&R, MSA, DOE, IQ/OQ/PQ and GLP.Able to recognize non-conformances from accepted and documented practices.Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization.Skilled at creating a cooperative team environment.Able to objectively evaluate situations and make recommendations for changes in light of overall project demands.Excellent verbal and written communication skills and flexibility to function in a fast paced and innovative environment.Ability to dive into details, translate and statistically analyze data, and effectively report results through written and/or graphical formats.Ability to facilitate large or small group meetings and manage conflict resolution.A positive approach to people and problem solutions along with a strong sense of discretion and the ability to maintain confidentiality.Ability to effectively use MS Office suite (Word, Excel, Outlook) and MiniTab and other applicable software packages.EXTRA AWESOME: Lean manufacturing and Six Sigma experience desirable.Certified Quality Engineer, Six Sigma Blackbelt, Quality Auditor, Reliability Engineer, or equivalent desired.WHAT'S IN IT FOR YOU? In addition to innovative technology, we have a culture that fosters the idea that the happiest people are the most productive people. Not only do we hire forward-thinking achievers to join our workforce; we reward, develop, and retain them too. Just one of the many reasons of how we #StayAwesome! To learn more about our culture and benefits please visit here.
BE YOU, WITH US! 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. But sometimes we forget that when we don't meet 100% of a job description's criteria – maybe you're feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us.
COMPENSATION & BENEFITS: The starting base pay range for this position is $180K - $234K annually. Base pay will vary based on job-related knowledge, skills, experience and may also fluctuate depending on candidate's location and the overall job market. In addition to base pay, Tandem offers a competitive compensation package that includes bonus, equity, and a robust benefits package. Tandem offers health care benefits such as medical, dental, vision, health savings accounts and flexible saving accounts. You'll also receive 11 paid holidays per year, a minimum of 20 days of paid time off (starting in year 1) and have access to a 401k plan with company match. Learn more about Tandem's benefits here! YOU SHOULD KNOW: Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer of employment from Tandem is contingent upon successful completion of a thorough screening process comprised of a drug test (excluding Marijuana) and background check, which includes a review of criminal history information.
Tandem has good cause to conduct a review of criminal history information of candidates for this position, as this role may involve access to proprietary, sensitive and/or confidential information, including customer protected health information. This review is required to ensure that individuals in such roles uphold high standards of trust and integrity so as to protect the interests of our customers, employees, and stakeholders.
REFERRALS: We love a good referral! If you know someone that would be a great fit for this position, please share!
The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.
SPONSORSHIP: Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

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