Sr. Quality Engineer I - Manufacturing / Sterilization

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 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.

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. May

·     Provides input to IQ/OQ/PQ development for processes and equipment.

·     Manufacturing and/or test fixture qualification (requirements, protocols, execution, test report)

·     Support the non-conforming material report (NCR) process and lead monitoring and tracking for open NCRs and ensure timely closures.

·     Lead and support 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.

·     Evaluate bioburden and sterility assurance data, investigate sterilization-related nonconformances, assess the impact of manufacturing or design changes on validated sterilization processes, and ensure continued state of control through data trending, risk assessment, and supplier oversight.

·     Review and approves COs as well as provides quality input.

·     Lead and support cleanroom environmental control programs to ensure compliance with ISO 14644, applicable regulatory requirements, and internal quality standards.

·     Monitor and trend environmental monitoring data, including viable and non-viable particulate results, investigate excursions and out-of-specification conditions, assess the impact of manufacturing changes on cleanroom performance, and drive corrective and preventive actions to maintain a validated state of control.

·     Review and approve environmental monitoring protocols, reports, and cleanroom qualification documentation.

·     Support cleanroom design, validation, requalification, and contamination control strategy activities.

·     Conduct investigations and root cause analyses for environmental monitoring excursions, contamination events, and adverse trends.

·     Collaborate with Manufacturing, Facilities, Microbiology, Validation, and Regulatory Affairs to ensure ongoing cleanroom effectiveness.

·     Evaluate gowning, cleaning, disinfection, and personnel monitoring programs for compliance and effectiveness.

·     Support risk assessments and change control activities affecting controlled manufacturing environments.

·     Provides quality input to Complaint, FA, CAPA investigations Independently completes such 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 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).

·     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 a 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.

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.

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.

WHY YOU’LL LOVE WORKING HERE:
At Tandem, we believe joy fuels excellence. That's why we've built a workplace that celebrates your achievements and  supports your well-being. Our team thrives on pushing boundaries and fostering growth, all while maintaining a spirit of fun and camaraderie.  This is just one of the ways we stay awesome! Explore the benefits and reasons to love Tandem at https://www.tandemdiabetes.com/careers.

BE YOU, WITH US!

We embrace the value that every single one of us brings 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. 

Tandem is firmly committed to being an equal opportunity employer and does not discriminate on the basis of age, disability, sex, race, religion or belief, gender identity or expression, marriage/civil partnership, pregnancy/maternity, or sexual orientation.  We are an inclusive organization, and we welcome applications from a wide range of candidates.  Selection for roles will be based on individual merit alone. 

REFERRALS:
We love a good referral! If you know someone who would be a great fit for this position, please share! 

APPLICATION DEADLINE: 
The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.

Make a move that matters. Join Tandem Diabetes Care, where we're turning challenges into triumphs every day and where your talents will help shape a healthier, happier tomorrow. 

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