Quality Management & Analytics Expert

Reposted An Hour Ago
Be an Early Applicant
Hiring Remotely in Office, Machaze, Manica, MOZ
Remote
Senior level
Healthtech
The Role
Support and optimize medical device Quality Management System processes (CAPA, complaints, audits, change/risk management). Create quality metrics, perform data analysis and predictive analytics, support regulatory implementation, coach teams, own/execute CAPAs, generate reports, and assist internal/external audits.
Summary Generated by Built In

Hybrid - Upon agreement between you and your supervisor, you are entitled to a flexible arrangement where you will be able to split your time between working from the office and working remotely.

Fresenius Medical Care core values:

Fresenius Medical Care is a people business. Our success depends on having the best and brightest employees, and helping them attain their personal and professional goals while delivering excellence in patient care and business results. Our employees embody our culture which is based on core values supporting our promise to improve the quality of life of every patient every day. These core values are: We Care. We Connect. We Commit.

As a Quality Management & Analytics Expert, you will support global product quality performance by collecting, analyzing and presenting quality data from manufacturing sites across the organization. You will work closely with quality, engineering and manufacturing stakeholders to identify trends, drive continuous improvement initiatives and provide meaningful insights that support business decisions. This highly collaborative global role offers exposure to a broad portfolio of life-sustaining medical devices and manufacturing operations worldwide. A significant part of the role involves consolidating quality data from multiple sites, identifying trends and presenting recommendations to management teams.

Responsibilities:

  • Collect, consolidate and analyze quality data and KPIs from multiple manufacturing sites and business functions.

  • Lead monthly quality performance reviews by consolidating data from manufacturing sites and facilitating discussions on quality trends, open CAPAs and improvement initiatives.

  • Transform complex quality data into clear business insights and recommendations for management decision-making.

  • Prepare regular quality performance reports and management summaries for leadership reviews.

  • Identify trends, risks and improvement opportunities through data analysis and quality metrics.

  • Support monitoring and reporting of key quality processes, including CAPA activities, product quality performance and continuous improvement initiatives.

  • Facilitate discussions with stakeholders on quality performance, open actions and improvement initiatives.

  • Contribute to the development and enhancement of quality reporting tools, dashboards and analytics.

  • Collaborate with manufacturing, engineering, product quality and other cross-functional teams globally.

  • Support implementation of quality system improvements and best practices across the organization.

  • Ensure high quality and accuracy of data used for quality performance monitoring and decision making.

Requirements:

  • Degree in Engineering, Technical or Scientific discipline.

  • Min 5 years of experience working within a Quality Management System environment.

  • Strong analytical and problem-solving skills.

  • Advanced Excel skills.

  • Ability to interpret complex datasets and translate findings into actionable recommendations.

  • Experience working with quality KPIs, reporting and performance metrics.

  • Fluent English.

  • Strong stakeholder management and communication skills.

  • Knowledge of CAPA and continuous improvement methodologies.

  • Understanding of Quality Management Systems and ISO-based quality standards.

  • Interest in learning about medical devices, products and manufacturing processes.

  • Experience with Power BI, Tableau or similar reporting tools is considered an advantage.

  • Experience in Medical Devices, Automotive, Pharma or other manufacturing environments would be beneficial.

Our offer:

  • Hybrid working mode (min. 2 days per week in the office)

  • Private medical care in LuxMed,

  • PZU life Insurance (voluntary insurance)

  • Unlimited international travel Insurance (with a global range)

  • Benefits System platform (120 points / month for multisport card, cinema tickets, online shopping etc.)

  • Language courses reimbursement (up to 70% of course reimbursement)

  • Studies reimbursement (up to 50% of study reimbursement)

  • Work abroad possibility (up to 30 days / year)

  • Recommendation programme (2000 PLN or 2500 PLN for successful recommendation)

  • Holiday allowance (up to 800 PLN / year)

  • Childcare refund (up to 900 PLN / year)

  • Glasses and contact lenses reimbursement (500 PLN per year)

  • Occasional gifts (e.g. 1st year anniversary gift)

  • Office team building activities and events

Skills Required

  • Degree in a technical or scientific discipline
  • More than 5 years of related experience
  • Knowledge of 21 CFR 820, ISO 13485, ISO 14971
  • Knowledge of MDSAP, EU MDD 93/42/EEC and MDR 2017/745
  • Fluent English
  • Highly developed analytical and statistical skills; Statistical techniques
  • Experience with CAPA process ownership and CAPA review
  • Experience supporting internal and external audits and regulatory process implementation
  • Process thinking, process authorship and continuous optimization mindset
  • Ability to maintain professional relationships, presentation and moderation techniques, conflict handling
  • Office tools: Excel, Word, PowerPoint
  • Experience with workflow/PDM/statistics tools (Trackwise, PTC Windchill, Minitab)
  • Knowledge of QMS tools like GPDM, QTRAK, QDATA
  • Familiarity with predictive analytics / AI for quality issue identification

Fresenius Medical Care Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Fresenius Medical Care and has not been reviewed or approved by Fresenius Medical Care.

  • Leave & Time Off Breadth PTO is described as ample for 3x12-hour shifts and is complemented by paid caregiver leave, holidays, and sick time. This range of time-off options provides meaningful flexibility for many roles.
  • Healthcare Strength Medical coverage includes 100% preventive care, office-visit copays, prescription coverage, and disability insurance, while dental covers preventive, basic, and major restorative services up to an annual limit. Vision benefits are also available.
  • Wellbeing & Lifestyle Benefits Wellness programs feature the Rally app with fitness rewards, virtual therapy, and an Employee Assistance Program with free counseling. Additional offerings like digital physical therapy and expert medical opinions broaden holistic support.

Fresenius Medical Care Insights

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The Company
HQ: Bad Homburg v. d. Höhe
42,197 Employees

What We Do

Fresenius Medical Care is the world’s leading provider of products and services for individuals with renal diseases. We aim to create a future worth living for chronically and critically ill patients – worldwide and every day. Thanks to our decades of experience in dialysis, our innovative research and our value-based care approach, we can help them to enjoy the very best quality of life. Our portfolio encompasses a comprehensive range of high-quality health care products and services as well as various dialysis treatment options for both in-center and home dialysis that are individually tailored to our patients’ needs.

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