Quality Assurance Engineer

vor 1 Woche

SaintSulpice VD, Waadt, Schweiz Tandem Diabetes Care Switzerland Sàrl Vollzeit

Tandem Diabetes Care Switzerland Sàrl, a subsidiary of Tandem Diabetes Care, Inc., is a MedTech start-up located in EPFL's Innovation Park in Lausanne, Switzerland. Tandem Diabetes Care, Inc., is a global insulin delivery and diabetes technology company based in San Diego, California. Together we are creating new possibilities for people living with diabetes, their loved ones, and the healthcare providers through a positively different experience.

Quality Assurance Engineer

GROW WITH US:

Tandem Diabetes Care Switzerland Sàrl, a subsidiary of Tandem Diabetes Care, Inc., is a MedTech start-up located in EPFL's Innovation Park in Lausanne, Switzerland. Tandem Diabetes Care, Inc., is a global insulin delivery and diabetes technology company based in San Diego, California. Together we are creating new possibilities for people living with diabetes, their loved ones, and the healthcare providers through a positively different experience.

INNOVATE EVERYDAY:

Tandem Diabetes Care Switzerland is developing SigiTM, a next-generation insulin "patch pump" that will offer additional treatment options for people with diabetes. This pump is based on a patented microfluidics technology developed in-house over the past 6 years. You can find out more about Sigi here.

A DAY IN THE LIFE:

The Quality Assurance Engineer will work with the Quality Assurance Team Lead to provide general support for the Quality department with a focus on QMS processes, procedures and documents to ensure compliance to Tandem's Quality Management System (QMS). The Quality Assurance Engineer will understand quality systems and processes and will facilitate optimization and continuous improvement of QMS to meet department, business, and company objectives.

Working from Tandem Diabetes Care Switzerland's office onsite in Switzerland, you'll have to....

  • Continuously support the QA team and stakeholders to develop, implement and maintain QMS documentation as required.
  • Continuously seek to improve quality system, evaluate processes and methods, and recommend best practices.
  • Participate in Document Control activities.
  • General administrative and clerical duties to support QA team.
  • Support change impact assessments and stakeholder analysis for QMS and devices related changes.
  • Develop and implement supportive communication plans to ensure stakeholders are informed of changes.
  • Coordinate and participate in QMS related NCs and CAPAs investigations and completions.
  • Continuously monitor completion of actions and communicate regularly with action owners to ensure timely and accurate NCs / CAPAs / COs processing.
  • Lead and support operational activities: incoming, in-process and final release activities.
  • Participate in internal audits conduction and findings investigation tracking.
  • Support Equipment management.
  • Support quality, regulatory and compliance audits.
  • Generate metrics, reports, data analysis and trending to demonstrate effectiveness of quality systems.
  • Ensure compliance with company policies, including Privacy/GDPR/HIPAA, and other legal and regulatory requirements.

YOU'RE AWESOME AT:

  • Knowledge of ISO, FDA, GDP and GMP concepts and guidelines.
  • Ability to interface with multiple levels of people in the organization, including manufacturing personnel and senior management.
  • Able to communicate effectively in verbal and written form.
  • Able to review, trend, analyze and report data using quality databases and/or Excel.
  • Able to react to changing situations in a timely, calm, and confident manner; able to work in dynamic, fast-paced work environment.
  • Proficient in Microsoft Office (Word, Excel, Outlook, PowerPoint). Must be an Intermediate/Advanced user in Excel. Ability to use pivot tables desirable.
  • Demonstrated problem solving ability.
  • Experienced Internal Auditor preferred.
  • Demonstrated ability to work independently, accurately and with initiative and handle multiple priorities with minimal supervision.

YOU'LL NEED:

  • Bachelor's degree in biomedical engineering, Life Sciences, Regulatory Affairs, or equivalent combination of education and applicable job experience.
  • 2 years' experience working as a Quality Engineer in a medical device, manufacturing or an FDA-regulated industry.
  • Experience in a GMP or ISO environment preferred.

BE YOU, WITH US

We are 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.

REFERRALS:

We love a good referral If you know someone that would be a great fit for this position, please share

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