Job Title: Quality & Regulatory Manager
Location: Brno, Czech Republic
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 17 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.
Who we are/ what we do
Q&R is a multi-disciplined team with objective input and 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 legislation and industry requirements and helping the organization to quantify and define what quality, compliance, and safety is to Perfect Quality System Health, Perfect Design, Perfect Order and Perfect Service, by monitoring and driving improvements through a structured operating rhythm.
- 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 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 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.
- Maintain awareness and understand operational impact of all relevant international product & environmental compliance requirements.
- 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.
- Oversees internal audits of various departments within BRNO site and coordinate remediation of findings.
- Be hands-on and ready to roll up the sleeves to fill in where required in meeting the site or departmental objectives.
- 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 directive, EMC directive, EN 61010-1, EN60204-1,EURATOM Ionizing Radiation Directive and Pressure Equipment Directive, and NFPA-79.
- Experience working in high-tech environment, and specifically capital equipment.
- 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 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 works with a sense of urgency and is results oriented.
- Excellent oral and written communications skills.