Quality Engineer

Project Role : Quality Engineer

Project Role Description : Enables full stack solutions through multi-disciplinary team planning and ecosystem integration to accelerate delivery and drive quality across the application lifecycle. Performs continuous testing for security, API, and regression suite. Creates automation strategy, automated scripts and supports data and environment configuration. Participates in code reviews, monitors, and reports defects to support continuous improvement activities for the end-to-end testing process.

Must have skills : Test Management

Good to have skills : NA

Minimum 3 Year(s) Of Experience Is Required

Educational Qualification : 15 years full time education

As IT Quality & Compliance Manager

You develop and apply common quality standards along our

System Development Life Cycle, based on existing concepts

and knowhow, in order to secure and strengthen confidence in

our IT Product Portfolios.

You keep up to date with regulations and closely collaborate

with our globally distributed units (Information Security, Data

Protection, QSHE and Pharma & Healthcare), so that you can

Streamline How Teams Can Best Meet The Higher Requirements

from customers and regulated industries.

You explore issues and challenges pertaining to quality and

compliance in the IT Product Portfolios, and provide support,

advice and coaching to help our Business Units/Operation

and Product Leads raising their level of quality and compli

ance.

You position yourself as a competent contact for all questions

concerning our quality standards and practices, and assist in

customer meetings and audits

You launch and lead internal awareness and training pro

grams for our quality standards.

Provide support and mentoring for development team mem

bers working in the area of quality management or compli

ance.

You are a competent advisor in all matters relating to process

documentation.

You actively support in building up and developing Center of

Excellence on topics such as CSV to gain and disseminate

acquired knowledge, skills and competences within KN.

(Pharma only) You take an active part in carrying out GxP

impact assessments and - where required - lead and carry out

Validation processes.

Practical experience in applying IT quality management effec

tively throughout a System Development Life Cycle.

Working with Management Systems, ideally for Quality and

Information Security, including handling of audits, documenta

tion requirements and compliance reporting (e.g. ISO 9001,

ISO 90003:2018 or ISO 27001).

Good understanding of complex enterprise software solu

tions, both self-developed and commercial off-the-shelf, with

a strong focus on quality, information security and data pro

tection.

Experience in auditing of IT processes.

Ability to communicate complex context on different levels of

management.

Ability to teach and train people.

Willingness to learn from each other and to share knowledge

and experience, in order to effectively improve the quality lev

el of the organization.

(Pharma only) Knowledge of existing regulation in Pharma

ceutical industry (FDA 21 CFR part 11 and 820, EU GMP An

nex 11)

(Pharma only) Experience in Computerized System Validation

methodologies and process, preferably based on GAMP5

framework., 15 years full time education