QA & RA Specialist (m/f/d)

Headquartered in Tokyo, Japan, Evident employs around 4,500 people at a total of 57 locations worldwide. Evident Europe, headquartered in Hamburg, Germany, employs approximately 770 people in 16 countries. The product portfolio includes a wide range of microscope systems used in clinical diagnostics, medical and basic research, as well as in various industrial areas. In addition, Evident offers videoscopes, products for non-destructive testing techniques and for X-ray fluorescence analysis.

Responsibilities

Quality

You are responsible for carrying out quality planning and risk analyzes in the course of development projects.
Supplier Management, -qualification and -audits - as well as the initiation of supplier development actions to maintain and continuously improve process and product quality are area of responsibility
You carry out internal root cause analyzes with subsequent initiation, monitoring and validation of corrective and preventive actions in collaboration with internal stakeholders
You are in charge of leading interdisciplinary project teams to introduce global process standards and key performance indicator requirements regarding the existing quality management system
You communicate with Evident organizations worldwide

Regulatory Affairs

Responsible for the coordination, evaluation and implementation of regulatory strategies and compliance programs through the review, consultation, training and support of each discipline (Engineering, Operations, Quality, Sales, Sourcing etc) to fulfill their business goals in a compliant manner.
Supports an effective interface between the respective disciplines and 3rd Party regulatory agencies (UL, CSA, TUV, Notified Bodies, FDA, ISO registrars, etc) and ensures this interaction follows the established best practice model for Evident Business.
Provides review, consultation and support for regulatory agency communications for Evident in EMEA
Should have a working knowledge of and eager to expand knowledge of the applicable standards and regulations that apply to Evident MIS (product safety standards like IEC 61010-1, EMC standards, etc) so that that RA team can disseminate and filter this information to the respective disciplines inside Evident and the regulatory agencies that Evident works with to establish a consistent compliance approach.
Participates in product reviews and ensures that the RA team provides a compliance review of each stage gate review for both internal product designs or changes and OEM branding projects.
Must support and help effectively manage through the RA team any identified non-conformity or product liability discovery or incident and assists with customer compliance issues.
Act as a change agent for improvement initiatives
Perform all job duties in a safe manner and obey all safety policies and procedures
Work on all tasks related to ISO standards, regulatory or statutory requirements.

Qualifications

B.S./B.A in technical related field.
5+ Years in QA/RA-Functions within the Life Science Industry
Profound knowledge of international regulatory requirements (ISO 9001, ISO 13485, EU MDR&IVDR, FDA, e.g.)
Profound knowledge in understanding and dealing with relevant directives and standards (such as the Machinery Directive, Low Voltage Directive, IEC 61010-/60601-1, EMC, CE, etc.)
Knowledge in Product and Process Development requirements for MD/IVD like useability, software development, risk management, e.g.
Knowledge in dealing with material compliance requirements (RoHS, REACH, e.g.)
Experience with coordination and communication of reportable events with competent authorities and notified bodies.
Experience in communicating with Regulatory Agencies
Strategic thinking and ability to partner with internal stakeholders at senior levels is required.
Experience in negotiation of quality related contracts like QAA’s.
Must possess sound organizational skills, demonstrate attention to detail and an ability to multi-task
Proven experience in problem solving
Excellent verbal and written communication skills
Flexibility to Travel (20%) in Germany + international (5%)

Your Benefits

Flexible working hours, 50% remote work possible
30 days of holiday per year
13,5 salaries a year
Modern office and inspiring working environment
Subsidized meals in the neighborhood of our office (Stadtküche)
Public transport ticket (100% subsidized) or free parking space
Bike leasing
Subsidy fitness first gym
Employee Assistance Program to support your health, mental and emotional well-being
Comprehensive company pension scheme
Joint company events and activities

Evident Europe GmbH is an equal opportunities employer and we look forward to receiving your application.