Danaher Corporation Quality Specialist in Amersfoort, Netherlands
Danaher Company Description
Since 1960, Ormco, one of the many successful companies owned by Danaher Corporation, has been developing, manufacturing, and marketing a broad line of orthodontic appliances and related products for sale in the U.S. and abroad. Ormco provides orthodontists with brackets, wires, adhesives, and ancillary supplies used through the course of treatment.
Ormco believes the direct contact of its sales force with orthodontists facilitates the identification and verification of market trends and new product opportunities. Ormco works closely with orthodontists to improve existing products and develop new products primarily through its Champion programs in which selected orthodontists assist Ormco in designing, developing and ultimately educating users on new product and technique innovations.
The associate in this position is the Quality Specialist ensuring Quality Control throughout the distribution process. Implements and supports processes to ensure labeling is according to regulations and meets customer requirements.
Optimization and support of incoming goods processing and handling of non-conformances. Supports and contributes to the internal audit process.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Quality Control related tasks on the work floor (labeling, product release, process checks, handling of non-conforming products.
- Calibration of equipment
- Handling of Non-Conformances process
- CAPA handling
- Process optimization support
- Evaluate discrepant material and provide advice and corrective actions to related departments on quality standards
- Handling of product quarantine holds to ensure regulatory compliance and communication to business owners.
- Evaluate discrepant material and provide advice and corrective actions related to departments on quality standards
- Conduct periodic scheduled ISO13485 internal audits with necessary follow up on corrective actions
Most Important Qualifications and Competences
MBO degree or experience equivalent.
At least 2 years experience in Quality Assurance/Quality Systems preferably in the Medical Device field.
Understanding of the quality system requirements such as ISO 13485 and European Medical Device Directive
Fluency in Dutch and English (written and spoken)
Excellent knowledge of MS Office (Powerpoint, Word, Excel and Access)
Basic knowledge in Oracle preferable
Ability to achieve results in a pragmatic, structured way, strong interpersonal skills and proactive working attitude in international matrix organization
Personal Trait Profile
Logical and creative thinker
Ability to influence others-credible
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Job Function: Quality and Regulatory Affairs
Primary Location: EMEA-Western Europe-Netherlands-Utrecht-Amersfoort
Req ID: ORM001460