Supplier and Quality (SQA) - ISO 13485

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

Job Description

 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: ₹800,000.00 - ₹1,000,000.00 per year

Schedule:

• Day shift
• Morning shift

Work Location: In person