Engineer, Quality Assurance

Stryker; Gurugram District; On-site; INR 600,000 - 1,200,000; Full time

Job summary

A leading medical technology company in Gurugram is seeking an experienced Quality Assurance Engineer. The role involves ensuring compliance with supplier control activities and conducting supplier audits. The ideal candidate should have a B. Tech degree and at least two years of experience in a quality or engineering environment, preferably in the medical industry. This full-time position aims to improve healthcare outcomes through innovative quality control practices.

Qualifications

• 2+ years of experience in Quality / Engineering / Manufacturing environment, preferably from medical industry.
• Proficient in advanced power BI applications.
• Working knowledge of basic and advanced Quality tools.

Responsibilities

• Ensure compliance to Supplier Control activities identified by organization.
• Conduct Supplier Audits and facilitate root cause analysis.
• Promote continuous improvement methodologies like Lean, Six Sigma.

Skills

Problem-solving methodologies

Communication skills

Quality control tools

Lean manufacturing

Education

B. Tech (Electronics/Electrical/Mechanical)

ISO 9001/13485 certification

Tools

Power BI

Six Sigma

FMEA

Job description

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• Ensuring compliance to Supplier Control activities identified by organization.
• Hands on experience of PPAP associated with New Product Launches and Management of Production cycles there after (Manufacturing Transfers).
• Participate in cross- functional teams in the development of new products or changes related to current products in meeting customer requirements.
• Applies sound, systematic problem-solving methodologies (5Why, DMAIC, 8D, C&E) in identifying, prioritizing, communicating, and resolving quality issues - NC & CAPA.
• Conduct Supplier Audits (Product, Process & System) and Facilitate root cause analysis and corrective actions of supplier quality issues.
• Evaluating Quality data to identify process improvement opportunities within the supply chain.
• Coordinate Change Management & Control with Suppliers and implement changes at Supplier.
• Promote the use of continuous improvement methodologies such as Lean, Six Sigma, Poka- Yoke (Error Proofing), Measurement System Analysis (MSA), Statistical process control (SPC) and Process Failure Mode and Effects Analysis (pFMEA)
• Review development protocols including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Special Process Validations, and Test Method Validations.
  
  

What you will do:

• Ensuring compliance to Supplier Control activities identified by organization.
• Hands on experience of PPAP associated with New Product Launches and Management of Production cycles there after (Manufacturing Transfers).
• Participate in cross- functional teams in the development of new products or changes related to current products in meeting customer requirements.
• Applies sound, systematic problem-solving methodologies (5Why, DMAIC, 8D, C&E) in identifying, prioritizing, communicating, and resolving quality issues - NC & CAPA.
• Conduct Supplier Audits (Product, Process & System) and Facilitate root cause analysis and corrective actions of supplier quality issues.
• Evaluating Quality data to identify process improvement opportunities within the supply chain.
• Coordinate Change Management & Control with Suppliers and implement changes at Supplier.
• Promote the use of continuous improvement methodologies such as Lean, Six Sigma, Poka- Yoke (Error Proofing), Measurement System Analysis (MSA), Statistical process control (SPC) and Process Failure Mode and Effects Analysis (pFMEA)
• Review development protocols including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Special Process Validations, and Test Method Validations.
  
  

What you will need:

Required Qualification:

• B. Tech (Electronics/Electrical/Mechanical) with 2+ years of experience in Quality / Engineering / Manufacturing environment, preferably from medical industry.
• Proficient in advanced power BI applications.
• ISO 9001/13485 certification.
  
  

Preferred Qualification:

• Working knowledge of basic and advanced Quality tools such as Six Sigma, SPC, FMEA, Control Plans, Root Cause Analysis, Poke Yoke, Kaizen, Lean Manufacturing etc.
• Strong communication skills. Must demonstrate the ability to communicate up/down and across different levels of the organization.
• Structurally collects facts to base his/her opinions on and ensures data integrity and traceability of data is flawless
  
  

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering and Information Technology

• Industries

  Appliances, Electrical, and Electronics Manufacturing, Industrial Machinery Manufacturing, and Medical Equipment Manufacturing

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