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QM Process Specialist

Company Description

medmix is a global leader in high-precision delivery devices. We occupy leading positions in the healthcare, consumer, and industrial end-markets. Our customers benefit from our dedication to innovation and technological advancement that has resulted in over 900 active patents. Our 14 production sites worldwide, together with our highly motivated and experienced team of nearly 2’700 employees provide our customers with uncompromising quality, proximity, and agility. medmix is headquartered in Baar, Switzerland. Our shares are traded on the SIX Swiss Exchange (SIX: MEDX).

www.medmix.swiss

Job Description

  • Write global policies, taking into account lean and least burdensome principles and applicable laws, standards and internal requirements. Ensure alignment with site responsible functions prior to roll-out
  • Help to create and structure the global process landscape, gathering feedback and continuously analyzing improvement needs
  • Act as ambassador of a global QMS, through training
  • Coach local process owners in interpreting global process expectations, support process owners with process issues/problems and reviewing for improvement opportunities
  • Ensure consistent and timely quality KPI reporting at global and BU level, collect and review site KPI information for consistency of data and trends
  • Assist the Quality Managers in defining data sources related to quality KPI reporting
  • Support Global and Local Quality Management as requested in cross-site activities to resolve business critical issues in the marketplace (e.g. complaints, CAPA's, audits or similar)
  • Act as Business Application Owner for medmix document management system

Qualifications

  • University degree in technical engineering or life sciences or higher specialized training in a technical or scientific field with extended training in standards and tools relevant to quality management
  • Experience in Quality Management in the field of Medical Devices
  • Extensive practical experience of handling typical quality tools like complaints, non-conformities, CAPA and Audit as well as basic understanding of handling quality topics in a production environment
  • In-depth experience with laws and standards related to Medical Devices (e.g. ISO 13485, MDR, QSR.)
  • Proficient experience in implementing and adapting software tools (ERP, MES, CAQ and DMS, Excel) for quality purposes
  • Proven ability to easily convey complex relationships to different audiences
  • Very good knowledge of written and spoken English and German (C1 Level for both)
  • Flexibility in daily working hours as required to accommodate different time zones for online collaboration

Additional Information

  • Working in highly motivated, international team with dedicated people who put the needs of patients at the center of their doing
  • Flexible hybrid working environment
  • 30 days vacation
  • Pluxee Card Benefits
  • Company pension plan
  • Capital-forming benefits
  • Performance-related salary, many attractive social benefits and a flexible and modern international working environment

medmix is an equal opportunity employer, committed to the strength of a diverse workforce.

93% of our employees would go above and beyond to deliver results – do you have the drive to succeed? Join us and boost your career, starting today!

Average salary estimate

$70000 / YEARLY (est.)
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$60000K
$80000K

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What You Should Know About QM Process Specialist , medmix

Are you an experienced QM Process Specialist looking to make a significant impact in the healthcare industry? Look no further than medmix, a global leader in high-precision delivery devices. Based in Stuttgart, Germany, we pride ourselves on our dedication to innovation and excellence, backed by over 900 active patents and a robust global production network. As a QM Process Specialist, you will play a crucial role in shaping and maintaining our global Quality Management System (QMS). Your responsibilities will include crafting global policies that reflect lean principles while ensuring compliance with relevant laws and standards. Additionally, you will be instrumental in creating and structuring our global process landscape while acting as an ambassador for the QMS through comprehensive training. You'll collaborate closely with local process owners to address challenges and identify areas for improvement, all while ensuring that our quality KPIs are reported consistently at both global and business unit levels. With your university degree in technical engineering or life sciences and your in-depth experience with quality management in medical devices, you are well-equipped to handle our challenging yet rewarding environment. Join our dedicated international team, enjoy flexible hybrid working conditions, and thrive with opportunities for professional growth. Are you ready to boost your career with medmix?

Frequently Asked Questions (FAQs) for QM Process Specialist Role at medmix
What are the key responsibilities of the QM Process Specialist at medmix?

The QM Process Specialist at medmix is responsible for writing global policies that adhere to lean principles and applicable laws, helping to create a structured global process landscape, and acting as a training ambassador for our global QMS. Additionally, this role involves coaching local process owners, ensuring effective quality KPI reporting, and supporting quality management efforts across various sites.

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What qualifications do you need to be a QM Process Specialist at medmix?

To excel as a QM Process Specialist at medmix, candidates should possess a university degree in technical engineering or life sciences, complemented by extensive experience in Quality Management in the medical devices field. Familiarity with ISO 13485, MDR, and QSR standards is essential, along with solid experience using quality tools like CAPA and audits.

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How important is language proficiency for the QM Process Specialist position at medmix?

Language proficiency is crucial for the QM Process Specialist role at medmix. Candidates must demonstrate a C1 level proficiency in both written and spoken English and German, ensuring effective communication with diverse teams and stakeholders across our global operations.

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What types of software tools will a QM Process Specialist use at medmix?

A QM Process Specialist at medmix will utilize various software tools, including ERP, MES, CAQ systems, and document management systems (DMS) to manage quality-related processes efficiently. Proficient use of Excel will also be essential for quality data reporting and analysis.

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What is the work culture like for a QM Process Specialist at medmix?

At medmix, the work culture for a QM Process Specialist is vibrant and highly collaborative. You will work in a motivated international team that prioritizes patient needs and fosters a flexible, modern work environment with a strong emphasis on career development and social benefits.

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Common Interview Questions for QM Process Specialist
Can you explain your experience with quality management in medical devices?

When answering this question, highlight your previous roles and specific responsibilities related to quality management, especially your familiarity with key regulations such as ISO 13485. Discuss how you've implemented quality improvement measures and handled complaints, non-conformities, or CAPAs.

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What strategies do you use to ensure compliance with quality standards?

Talk about your experience in developing and implementing quality management systems and your methods for conducting audits. Mention specific strategies like continuous training for staff and regular monitoring of quality metrics to ensure compliance.

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How do you handle conflicts with local process owners regarding quality standards?

Focus on your conflict resolution skills by providing examples of how you've navigated disagreements in past roles. Emphasize your approach to facilitate open communication, understanding stakeholders' perspectives, and finding common ground to resolve issues.

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What tools do you find most effective for reporting quality KPIs?

Discuss the quality tools you've used in reporting KPIs, including software systems like ERP and Excel. Explain your methodology for gathering, analyzing, and presenting data to ensure clarity and support decision-making.

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Can you describe a challenging quality issue you've resolved in your previous experience?

Share a specific example of a quality issue you've faced, detailing the context, your analysis, the steps you took to resolve it, and the overall outcome. This demonstrates your problem-solving skills and experience in the field.

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How do you prioritize tasks when managing multiple quality projects?

Explain your strategies for task prioritization, such as assessing the urgency and impact of each project, and how you communicate with stakeholders to manage expectations. Mention any tools or methods you use for time management.

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What role do you believe training plays in a QMS?

Discuss the significance of training in a QMS, emphasizing its impact on consistency, employee engagement, and overall quality culture. Share sample training programs you've developed or implemented in previous roles.

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How do you ensure your policies are understood and adopted by teams?

Talk about your approach to communication and training when rolling out new policies. Share how you involve stakeholders, seek feedback, and adapt your communication strategies to diverse audiences to ensure understanding and adoption.

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What metrics do you believe are essential for assessing quality performance?

Identify key quality performance metrics relevant to the QM Process Specialist role, such as defect rates, customer complaints, and audit results. Discuss why these metrics are important and how they can drive improvements.

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How do you stay current with changes in quality legislation and standards?

Share your strategies for staying updated, such as attending conferences, participating in webinars, joining professional organizations, or subscribing to industry publications. Highlight any certifications you hold and their relevance.

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DATE POSTED
April 17, 2025

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