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Position – QA Engineer

Sartorius Stedim Biotech
Location – Bengaluru, Karnataka

The QA Engineer will be responsible for coordinating with the team and verifying quality standards in accordance with the requirements of Sartorius. The holder of this position serves as the liaison for Bio stat project and is in charge of performing inspection & documentation activity to ensure compliance with regulatory standards, as well as actively participating in strategic development based on quality control plans

Main Responsibilities & Tasks:

Bachelor’s degree in Mechanical engineering
2+ years’ experience in QA ideally within the biomedical or pharmaceutical industry
Knowledge of Quality systems
Good Technical Engineering knowledge, including the ability to understand engineering drawing and standards
Ability to develop realistic work plans set personal goals that align with company goals
Well-organized and methodical, with superb attention to detail
Ability to prioritize and manage daily assignments
Excellent written and verbal communications skills to represent the company professionally
Establish and maintain positive working relationships with all in and external interfaces
Fluent in English

Sartorius Stedim Biotech
Location – Bengaluru, Karnataka

In defined development projects, you ensure that APQP and PPAP are worked out for the respective gate reviews and approve them.
You ensure the development of production control plans, work- , inspection- and qualification instructions and the execution of initial sampling according to SOP.
You thus ensure that specifications are translated into attributes and that compliance with them is validated on the product and in the process, and also provide for capability analyses for this purpose.
You set and implement the standards for creating data-based qualification and validation protocols (product, process, equipment, CSV, …).
Furthermore, you will be responsible for the (further) development of the error catalog and apply it in the FMEAs with the aim of reducing quality problems.

Degree in mechanical engineering, process engineering or industrial engineering.
3 to 5 years of relevant professional experience in quality management and are an expert in the moderation and implementation of FMEA, Quality-function deployment (QFD), in the application of APIS PLATO e1ns.
You are very confident in the implementation of regulatory requirements according to ISO 9001 | 13485 | 14000, GMP, IATF 16949, VDA 6.3.
Furthermore, you have experience in project management as well as in the application of Six Sigma methods, MSA and SPC.
You have an expert level in the use of MS Office package as well as SAP E2P.