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Manager, Quality Assurance

vor 7 Monaten

SaintSulpice, Schweiz Tandem Diabetes Care Switzerland Vollzeit

**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 Sigi, 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**:

- Manages, implements, and maintains the electronic document management system (EDMS) and associated processes in compliance with the applicable standards and regulations.
- Manages process improvement initiatives and collaborates for overall Quality Management System (QMS) process improvements.
- Serves as Subject Matter Expert for quality system processes and provides input to procedures (e.g., Quality System Procedures, Work Instructions etc.) to ensure compliance.
- Leads and manages EDMS improvements including validation and implementation activities.
- Manages activities of the change control process to ensure issues are appropriately evaluated.
- Performs internal audits of the Quality Management System (QMS) as a certified Internal Auditor for Tandem and leads external audits.
- Builds and maintains relationships with cross functional teams and relevant stakeholders including functional heads, to support best practices, create and improve processes.
- Assigns and oversees projects and activities for Quality Assurance team personnel including training company-wide personnel on EDMS or document control processes and generating metrics for management review.
- Hires, trains, develops, and coaches Quality Assurance team personnel.
- 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.
- Supports short term planning for the QA team including headcount, budgeting, training, and systems requirements.
- Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
- Other responsibilities as assigned.

**YOU’RE AWESOME AT**:
**1. Knowledge, skills & abilities**:

- Knowledge of ISO 13485, MDSAP, FDA, MDR, Good Documentation Practices (GDP), and cGMP concepts and guidelines.
- Excellent writing and editing skills.
- Ability to work on multiple assignments in collaboration with cross functional teams.
- Skilled at presenting information in a clear and concise manner to all levels within, and outside of, the organization.
- Proactive approach and strong critical thinking skills.
- Consistently contributes to team initiatives in a comprehensive and timely manner.
- Reacts to changing circumstances in a timely, calm, and confident manner.
- Proficient with EDMS.
- Fluent in French and English (C1 proficiency minimum).

**2. Minimum certifications/educational level**:

- Master's degree in Biomedical Engineering, Life Sciences, or equivalent combination of education and applicable work experience.
- Certified Quality Engineer, Six Sigma Blackbelt, Quality Auditor, Reliability Engineer, or equivalent desired.

**3. Minimum experience**:

- 8 years’ experience within an FDA regulated or ISO 13485 certified industry.
- 2 years of previous management experience required.

**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. We offer:

- A high-tech and innovative environment in MedTech
- Excellent working conditions, autonomy, being part of a motivated and highly qualified team
- Interesting and stimulating work in an innovative field with high potential
- Pleasant environment within the EPFL Innovation Park, with possibility to benefit from the campus infrastructure

**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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