Quality Engineer

Náplň práce, právomoci a zodpovednosti:

About the role:

Quality Engineer role manages the performance of the Engineering aspects of the site’s Quality System and Quality Control processes in achieving all established user requirements and all applicable regulatory agency requirements. The role ensures compliance with Corporate Quality System procedures during Process Development, Design Transfer, Process Validation, Launch and Engineering Change activities. Collaborates with internal suppliers and customers to establish product quality requirements.

Your key duties and responsibilities as a Quality Engineer:

• Actively supports and influences technology transfer teams in the translation of product Design

• Requirements into Manufacturing Requirements; including the Quality Control Plan and ensures that these

• are included in the Design and Development Plans and addressed timely in Design Reviews. Assures work

• is complete, meets standards and requirements appropriate for the type of product

• Supports the introduction of new GxP equipment into production, providing guidance and enforcing high

• quality standards throughout the respective project

• Supports the implementation of continuous improvement activities by assessing impact on the Quality

• system and providing guidance on appropriate activities required for implementation

• Investigates process and product performance issues and leads or participates in multifunctional evaluation

• of products in the market

• Evaluates data using statistical tools

• Lead or support Complaint investigations through Root Cause Analysis and effective Corrective or

• Preventive Actions (CAPA)

• Lead or actively support Product Change Control

• Supports manufacturing, providing guidance to ensure high quality standards are maintained

• Performs and/or supports investigations relating to Manufacturing/validation/equipment issues

• Provides leadership as subject expert in Risk management and Control plan activities. Maintains risk

• management procedures, ensuring alignment with relevant regulatory standards

• Provides leadership as subject expert in validation, completes assessment of validation requirements

• associated with a change in the process

• Maintains validation procedures, ensuring alignment with relevant regulatory standards

• Participate in revalidation assessments for GxP processes across site in compliance with Site Master

• Lead/Participate Process FMEA,

• Update HAR, UFMEA or DFMEA

• Perform HHE, stopships

Zamestnanecké výhody, benefity:

• Quarterly bonus after the trial period - max. 10% from the monthly salary of the employee (based on the results of the production plant).
• Large corporation with representation and manufacturing plants in the world.
• Stable employer for Michalovce city and its surroundings.
• Corporate culture – Underpinning everything we do are our values: 

- Improve care 

- Deliver results 

- Grow together 

- Own it 

- Do what´s right 

• Home office possibilities.

• Flexible working hours.

• Introduction program according to company standards.

• Development trainings.

• Career opportunities for internal employees. 

• Referral bonus system.

• Recognition program.

• Meals in the amount of 0.44 Eur per one meal unit / day.

• Supplementary pension plan after the trial period with the employer's contribution. 

• Social fund (various support and perks for employees).

• Free bus transport within Michalovce city.

• Various events / team building activities for employees.

• Various employee discounts by vendors within Michalovce city. 

Informácie o výberovom konaní:
Only candidates who meet our requirements will be invited for the interview. Data of not selected candidates will be deleted in compliance with GDPR and data protection law.
Information about personal data processing of job seekers is located on link: https://www.convatec.com/sk-sk/o-nas/kariera/

Požiadavky na zamestnanca:

About you:

• Demonstrated experience in Pharma/Medtech industry - preferred

• Knowledge and experience of working with a Quality Management System within Medical Device

• manufacturing

• Demonstrated experience in a quality engineering or a similar role in a medical device or life sciences

• technology driven company

• Demonstrated application of change control processes in a complex and regulated manufacturing

• environment

• Experience with all phases of the product development lifecycle including concept, design, implementation,

• verification, and validation activities necessary for product commercialization.

• Regulatory and compliance knowledge and expertise in quality systems and medical devices: QSR Part 820, ISO 13485, MDD 93/42, GMP Parts 201 and 211

• Project management expertise including managing multiple projects – preferred

• Position is also suitable for a fresh graduate

Education / Qualifications:

• University degree (engineering or scientific discipline is preferred)

• Proficient with software such as Word, Excel, PowerPoint, and Project, as well as statistical tools (e.g.

• Minitab)

• Knowledge of  ISO 13485, ISO 9001 -  preferred

Our ambitions will bring the very best out in you. You’ll  be pushed  to aim higher and really own  your work. You’ll  be encouraged and supported to make things  happen, too. 

It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth  it.

This is stepping up to a challenge.

This is work  that’ll  move you.