Sartorius Hiring for Project Quality Planning Engineer at Bengaluru, Karnataka, India Full Time

Job Description

For Sartorius Stedim India Pvt. Ltd, we are currently seeking a Project Quality Planning Engineer To join our team in Bangalore. In this position, you will act as a critical partner to our Operational Quality Bioprocess Solutions division and will be responsible for ensuring the quality requirements for products from internal and external suppliers (D-FMEA). At the same time, the Project Quality Planning Engineer ensures compliance with quality standards in design and manufacturing processes (P-FMEA).

What you will accomplish together with us:

• You ensure continuity between functional analysis, FMEAs, list of critical and special product and process characteristics, control plan, work, and inspection instructions in assigned project
• You lead risk assessments in projects for quality problems
• You ensure the development of production control plans as well as work, inspection and qualification instructions and the execution of initial sampling according to SOP
• You ensure that specifications are translated into attributes.
• You ensure that the conformity for the product is validated and, in the process, and provide capability analysis for this purpose
• You carry out initial sampling in accordance with valid SOPs
• You participate actively or facilitate Design and Process FMEAs
• You supervise, define scope, and approve process and measurement system capability assessments (internal and at vendors)
• You oversee and actively participate in investigations according to 8D principles for all critical and major deviations related to product and process qualifications and to product compliance if required you escalate to the next level.
• In addition, you ensure the best practice transfer with other Sartorius locations on a global level
• With your experience in various quality methodologies during product development, you create a common understanding of the advantages of implementing quality methods among all relevant stakeholders

What will convince us:

• You have successfully completed your degree in mechanical engineering, engineering, or a comparable field
• You have approx. 5 years of professional experience in quality management and have expertise in the moderation and implementation of FMEAs
• 3+ years in project management as well as in the application of Six Sigma methods, MSA and SPC.
• You can demonstrate reliable knowledge of the regulatory environment (such as ISO9001 | ISO13485 | Gxp | VDA 6.3)
• You are safe in using the common MS Office tools and SAP E2P
• You have a persuasive personality paired with assertiveness and very good communication skills complete your profile
• We assume a good knowledge of English
• You are willing to travel globally (25%)
• You identify with our values: sustainability, openness, joy

What we offer

Our ambition is to simplify progress in life science research and the biopharmaceutical industry to help translate scientific findings into new therapeutics faster and more efficiently. So that more people can obtain access to better medicine. Nearly 11,000 employees at more than 60 production and sales locations worldwide are committed to this vision. And together, we have grown strongly over the past years. Do you also want to contribute to our vision? Grow with us and benefit from working with a Global Player that has kept its familiar atmosphere: Opportunity for international career development: a global network offering seminars and training sessions, expert, and manager career paths Open and highly collaborative culture: mutual support within teams and working as equals, team spirit and international collaboration Work-life balance: Working from home at many sites Intelligent working environment: working in smart buildings with the latest technology and equipment Ambitious goals: Sartorius plans to double its sales revenue approximately every five years and expects to grow its global team to approximately 15,000 people in 2025. We look forward to receiving your application. www.sartorius.com/career We look for employees who would like to grow with us and move the innovative life sciences sector forward. In the process, we focus on agile project work, mutual support within teams and working as equals. Sartorius thrives as a company with people who give their very best every day and who are eager to develop personally and professionally.
Further insights into our world of work can be found here.