PS - Quality Systems- Capability/Consumer Comments /Digital

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)