QUALITY & REGULATORY MANAGER

KVALITA A BEZPEČNOST / QUALITY

As the world’s leader in serving science, Thermo Fisher Scientific is a driving force in the research, healthcare, industrial and applied markets, generating more than USD 20 billion in annual revenue. No other company can match our range of customer touch points – technologically, geographically or commercially. We help our customers in finding cures for cancer, protecting the environment, making sure our food is safe and moving forward with thousands of important projects that improve millions of lives.

At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission - enabling our customers to make the world healthier, cleaner and safer.

Quality & Regulatory Mission:

Q&R is a multi-disciplined team with expertise in Quality systems, business process excellence, structured problem solving, Environmental Health & Safety and regulatory compliance.

We support our brand with regard to fulfilling customer needs, compliance to international legislation and industry requirements, helping the organization to quantify and define what quality, compliance, and safety is, by monitoring and driving improvements through a structured operating rhythm to achieve Perfect Quality System Health, Perfect Design, Perfect Order and Perfect Service.

Key Responsibilities:

  • Drive Customer satisfaction
  • Support the organization with strategy deployment and KPI leadership management.
  • Measure and improve core QA processes (e.g., Internal Audit, CAPA, Non-conformity processes).
  • Ensure integrity in the documented Quality Management system.
  • Support the principle elements of Lean leadership (e.g., Daily Management / Accountability, Discipline and Leader Standard Work).
  • Serve as the primary liaison on quality for both internal and external suppliers, customers and stakeholders.
  • Manage the Q&R/EHS team in BRNO, Czech Republic.
  • Track and report on process quality trends, closely work with PLM to track and report on product quality trends.
  • Employ proven quality techniques to aide site management in problem solving.
  • Be a technical resource to guide site management in their responsibilities for EHS addressing a.o biosafety, chemical safety, laser safety and radiation safety.
  • Address Environmental, Health and Safety issues raised via the CAPA process.
  • Lead complaint handling initiatives escalated to Quality Assurance.
  • Respond to requests from customers.
  • Assures compliance with applicable internal and external regulations, policies and procedures related to Quality, EHS and product safety (e.g. LVD, EMC, Machinery, Euratom, REACH, RoHS and marking e.g. CE, NRTL).
  • Participate in audits conducted by regulatory agencies, customers and internal auditors.
  • Be hands-on and ready to roll up the sleeves to fill in where required in meeting the site or departmental objectives.

Minimum Wants:

  • 10+ years of quality and regulatory experience working in an ISO 9001/14001 environment.
  • A demonstrated working knowledge of CE standards and directives, e.g., Machinery and EMC directive, EN 61010-1 and a familiarity of Hazard Based Safety Engineering principles.
  • Bachelor’s engineering Degree or equivalent experience in a technical/scientific field.
  • Strong computer, technical skills, and data analysis and reporting using, Microsoft Excel, Access, Word, PowerPoint and Minitab.
  • Ability to travel domestically and internationally approximately ≤10% of the time.
  • Effective and persuasive communicator with the ability to effectively convey ideas to all levels of management.
  • Skilled problem solver who can work with a sense of urgency and is results oriented.
  • Excellent oral and written communications skills.

Location: CTP Brno - Slatina

CONTACT

Aleksandra Adamczyk

Vlastimila Pecha , Brno 627 00

aleksandra.adamczyk@thermofisher.com