Quality Engineer

Job Title: Quality Engineer,

Reports To Associate Quality Assurance Manager, Quality Engineering

Position Summary

General Skills

Working in partnership with the Global Supplier Network, you'll be involved in the ongoing support for the internal business units to address ongoing OEM/CM’s quality issues, development of suppliers and ensuring that our external supply chain is capable of meeting expectations from a quality, service and cost perspective.

You will serve as liaison between OEM/CM’s and Stryker to drive effective continuous improvement as a result of the supplier base. You will work with internal customers and OEM/CM’s in support of quality issues; provide technical support for activities related to quality system assessment and performance evaluation.

You will collaborate with the strategic sourcing, auditing and development groups to understand the capabilities and competencies of OEM/CM’s to meet our requirements and continually meet and adapt to our product quality and regulatory requirements.

This role will provide coaching and guidance to the OEM/CM’s team to ensure compliance to technical, regulatory and Stryker requirements.

• Basic Knowledge in statistics
• Good communication skills
• Strong team player
• Good understanding and ability to work with Microsoft Office
• Basic understanding of manufacturing processes
• Fluent in written & oral English
• Willing to travel in support of business needs to different geographical locations
• Basic understanding of project management
• Good interpersonal skills

Roles & Responsibilities

• Support the implementation of process improvements to Corporate/Site/Division Supplier Initiated Change Request procedures and process.
• Served as owner, execute, and maintain the electronic systems related to SICRs, and support data alignment (SICR Database & OnePLM SICR Library)
• Challenge suppliers SICRs forms for completeness and accuracy. Discuss corrections to the form to guarantee a smooth assignment and execution of the change.
• Own & Execute Supplier Initiated change request (SICR) submitted by Global Suppliers
• Review Submitted SICRs and challenge suppliers for missing information & required deliverables for approving the change
• Organize SCRB with Key Stakeholders and get Buy in for Type of change.
• Review and Approve deliverables submitted by suppliers and coordinate with supplier for any corrections.
• Execute ECR/ECNs and Promotion requests in OnePLM for Change Approval at Stryker end.
• Support communication tools to internal and external customers (suppliers/site/division)
• Monitor and Maintain SICR KPIs.
• Support Global SICR Initiatives and the CRT

Qualifications Knowledge Skills

Professional Requirements- Required:

• Honors Bachelor’s degree in Engineering or Science fields or equivalency.
• 4 to 5 years of experience in manufacturing environment or equivalent.
• Basic knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
• Good communication skills.
• Willing to travel in support of business needs to different geographical locations.
• Good knowledge of continuous improvement methodologies
• Hands on experience of PPAP ,MSA, SPC documentation creation, review and Approval from suppliers.
• Good Hands on experience of Validation activity – IQ,OQ & PQ
• Good Know how of Manufacturing processes like welding, Molding, Machining etc.
• Good Hands on experience of PFMEA & Control Plan

Personal Competencies

· Must enjoy working in team environment

· Must demonstrate good collaboration and communication skills.

· Highly motivated and able to build relationships internally and externally.

· Must demonstrate multitasking skills as this individual will be responsible for multiple tasks at the same time.

· The individual should enjoy working in a dynamic and results oriented team environment focusing on quality, compliance and customer satisfaction

Job Type: Full-time

Pay: ₹60,000.00 - ₹80,000.00 per month

Schedule:

• Monday to Friday

Application Question(s):

• Do you have 4-5 years of experience in a manufacturing environment with knowledge of GMP, ISO 13485, and 21 CFR Part 820? Describe your experience.
• Have you led or contributed to PPAP, MSA, SPC, or validation activities (IQ/OQ/PQ)? Provide an example.
• Describe your experience working with suppliers/OEMs on process improvements or change requests (SICRs/ECNs). How did you ensure compliance?
• Are you willing to travel as needed for supplier audits or quality issue resolution?
• Explain a time you identified a manufacturing process risk (e.g., via PFMEA). How did you mitigate it?

Language:

• English (Required)

Location:

• Gurugram, Haryana (Required)

Willingness to travel:

• 25% (Required)

Work Location: In person