AdresseJob Location
Marktheidenfeld
Job Description
SITE QA COMPLIANCE Leader
The Site QA Compliance Leader should be a quality professional with previous experience in the medical device industry. Analytical, proactive, can-do attitude, strong collaboration skills and quality mindset to do the right thing and drive continual improvement in our systems and processes, with excellent written and verbal communication skills in English and German.
RESPONSIBILITY
Implement and manage an effective quality and compliance program according to:
External regulatory requirements like MDSAP, ISO 13485:2016, ISO 9001:2015, Anvisa, FDA 21 CFR Part 820, CMDR SOR/98-282.
Internal P&G requirements including WQA, One-Health, GIC-K.
Compliance Trending and Regulatory Newsletters.
Develop and periodically review an effective Quality Management System with focus on strong foundations and continual improvement.
Identify risks and gaps with standard tools.
Create and manage effective action plans in response to audits.
Audit Organization and support for:
External authorities, e.g. FDA, Anvisa, TÜV,
Internal P&G Assessors
Job Qualifications
Implementation and maintenance of Quality Management Systems
Performing Risk Analysis and FMEA
Production of Medical Devices
Project management
Methodical and diligent execution with excellent planning skills
Ideally ISO 13485 / MDSAP certified auditor
EOQ Quality Auditor
Very well completed university studies (University/FH) in the technical field (mechanical engineering, electrical engineering, automation technology, mechatronics, process and process engineering, industrial engineering)
Very good analytical skills and quick comprehension
Initiative, flexibility and ability
Internships and/or stays abroad
Good knowledge of English and German
Job Schedule
Full time
Job Number
R000100361
Job Segmentation
Experienced Professionals (Job Segmentation)
P&G was founded over 180 years ago as a simple soap and candle company. Today, we’re the world’s largest consumer goods company and home to iconic, trusted brands that make life a little bit easier in small but meaningful ways. We’ve spanned three centuries thanks to three simple ideas: leadership, innovation and citizenship.
The insight, innovation and passion of talented teams has helped us grow into a global company that is governed responsibly and ethically, that is open and transparent, and that supports good causes and protects the environment. This is a place where you can be proud to work and do something that matters.
