QMS Manager

German multinational company operating in the medical devices field is looking for a Quality Standards Manager:

Responsible for ensuring consistent quality of production processes by developing and implementing sustainable automated manufacturing practice systems. The goal is to develop and direct quality assurance procedures so that the products meet internal and external standards before shipment to customers.

Main Responsibilities & Tasks:

Design and implement quality standards and achieve quality assurance operational objectives by contributing information and analysis to strategic plans

Oversee internal processes and procedures to ensure quality and validate quality processes by establishing product specifications and quality attributes

Maintain and improve product quality by completing product and surveillance audits; investigate customer complaints

Develop quality assurance plans by conducting hazard analyses and identify critical control points and preventive measures

Regularly analyze quality data and suggest actions based on collected data

Collaborate with relevant interfaces to develop new product and engineering designs, and manufacturing and training methods

Update knowledge by studying developments in quality management

Qualifications & Skills:

Master's degree in Science, Engineering or related field

5+ years of experience in a similar role in a regulated industry

Excellent knowledge of methodologies of quality assurance and standards (relevant certification of quality control)

Excellent knowledge of ISO 13485 standards

Proven understanding of data analysis and statistical methods

Ability to build a strong relationship with stakeholders

Excellent communication and presentation skills

Critical thinker with problem-solving approach

Strong negotiation and leadership skills

Pronounced sense of ownership

Fluent in English