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Manufacturing Quality Engineer - AS353

Tech Mahindra Zelienople Contractor
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The Manufacturing Quality Engineer is accountable for driving change, establishing sustainable processes, improving products, and providing actionable process and product data. This position will have direct interaction with the Manufacturing and Engineering groups to support manufacturing sustaining activities, continuous improvement, and manufacturing capacity expansion. The position may also have responsibility for new product introduction (NPI) quality oversight. The position requires exceptional communication, interpersonal, and project management skills to effectively coordinate activities and deliver results. An understanding of the application of quality standards and regulations (21CFR 820, ISO-13485) is necessary. 

Job Details: 
• Provides focused quality engineering support and assumes responsibility for timely and effective coordination and/or execution of assigned project activities 
• Acts as an effective team member in supporting quality discipline, decisions, and practices 
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. 
• Generates internal quality documentation such as quality plans, master validation plans, validation protocols, inspection procedures, and standard operating procedures 
• Performs analytical measurements and experiments to qualify or resolve product and process issues 
• Tracks quality trends and initiates action items to resolve issues 
• Manages assigned corrective actions and drives them to closure 
• Provides consultation to end users and process owners with regard to data collection, analysis and creation of validation reports 
• Becomes familiar with the applicable technologies to facilitate participation in technical discussions and risk-based decision making 
• Reviews process validation reports and identify gaps for compliance 
• Coordinates issue resolution following a risk-based approach 
• Ensures manufacturing processes and validation programs meet requirements of FDA and ISO 
• Trends, analyzes, and reports on quality data in order to improve products and processes 


Candidate Qualifications: 

• Bachelor’s degree in an engineering or scientific discipline required 
• Organizational and time management skills essential for project work are required 
• Strong communication, facilitation, planning, and problem-solving skills are required 
• Good judgment and decision-making skills are required; knows how to make trade-off decisions while balancing compliance and business impact 
• Experience with quality and process improvement methodologies and tools required 
• Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands is required 
• Excellent computer skills are required 
• Three to five years of experience in a medical device quality assurance environment strongly preferred 
• One to two years of auditing experience preferred 
• Strong writing, mathematical, data-mining, trend analysis, and statistical skills are preferred 
• Experience with enterprise Quality System tools (e.g., electronic CAPA, Change Control systems) is preferred

Skills required

Sample Procedure
Quality Assurance
Performance Testing
Perform Inspection
Total Quality Management
Provide Technical Guidance
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Tech Mahindra represents the connected world, offering innovative and customer-centric information technology services and solutions, enabling Enterprises, Associates and the Society to Rise™. We are a USD 4.0 billion company with 107,100+ professionals across 90 countries, helping over 800 global customers including Fortune 500 companies. Our innovation platforms and reusable assets connect across a number of technologies to deliver tangible business value to our stakeholders. Tech Mahindra is also amongst the Fab 50 companies in Asia as per the Forbes 2015 List.

We are part of the USD 16.9 billion Mahindra Group that employs more than 200,000 people in over 100 countries. The Group operates in the key industries that drive economic growth, enjoying a leadership position in tractors, utility vehicles, information technology, after-market and vacation ownership.

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