About
Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers. The company manufactures and sells the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology.
A Day in the Life
An experienced senior team member in a sustaining, manufacturing environment with ample knowledge and experience in sterilization, bacterial endotoxin testing, and cleanroom activities providing quality guidance and support for product launch, sustaining engineering, and quality system activities to ensure 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 patient safety, product quality and business operations.
Responsibilities
•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.
•Manufacturing and/or test fixture qualification (requirements, protocols, execution, test report).
•Supports the non-conforming material report (NCR) process and leads monitoring and tracking for open NCRs and ensures timely closures.
•Leads and supports sterilization validation activities, including dose establishment, dose audits, requalification, and routine monitoring in compliance with ISO 11137, ISO 13485, FDA QMSR, and applicable regulatory requirements.
•Evaluates bioburden and sterility assurance data, investigates sterilization-related nonconformances, assesses the impact of manufacturing or design changes on validated sterilization processes, and ensures continued state of control through data trending, risk assessment, and supplier oversight.
•Reviews and approves COs as well as provides quality input.
•Leads and supports cleanroom environmental control programs to ensure compliance with ISO 14644, applicable regulatory requirements, and internal quality standards.
•Monitors and trends environmental monitoring data, including viable and non-viable particulate results, investigates excursions and out-of-specification conditions, assesses the impact of manufacturing changes on cleanroom performance, and drives corrective and preventive actions to maintain a validated state of control.
•Reviews and approves environmental monitoring protocols, reports, and cleanroom qualification documentation.
•Supports cleanroom design, validation, requalification, and contamination control strategy activities.
•Conducts investigations and root cause analyses for environmental monitoring excursions, contamination events, and adverse trends.
•Collaborates with Manufacturing, Facilities, Microbiology, Validation, and Regulatory Affairs to ensure ongoing cleanroom effectiveness.
•Evaluates gowning, cleaning, disinfection, and personnel monitoring programs for compliance and effectiveness.
•Supports risk assessments and change control activities affecting controlled manufacturing environments.
•Provides quality input to Complaint, FA, CAPA investigations. Independently completes activities in Risk Analysis, Process Capability Analysis (Cpk), DFM, 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 the 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+ 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).
•Proficient knowledge and experience with sterilization, bacterial endotoxin testing, and cleanroom standards (ISO 11137-1, ISO 11137-2, ISO 11737-1, ISO 11737-2, ISO 11737-3, AAMI ST72, ISO 14644-1).
•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).
•Able to recognize non-conformances from accepted and documented practices.
•Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.
•Skilled at promoting team cooperation and a commitment to team success.
•Adept at seeing change as an opportunity to improve business performance and campaigning for it when necessary.
•Ability to effectively use MS Office suite (Word, Excel, Outlook) and MiniTab and other applicable software packages.
Extra Awesome
•Experience in an ISO environment preferred.
Compensation & Benefits
The starting base pay range for this position is $110K - $121K 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 and a robust benefits package.
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 pre-employment screening process comprised of a drug test (excluding marijuana) and background check, which includes a review of criminal history information. This role may involve access to proprietary, sensitive and/or confidential information, including customer protected health information, and Tandem has good cause to conduct a review of criminal history information of candidates for this position.
Sponsorship
Applicants must be authorized to work for any employer in the U.S. Tandem is unable to sponsor or take over sponsorship of an employment Visa at this time.
