Stryker Corporation is Hiring | Quality Engineer |

Position – Quality Engineer
Company – Stryker Corporation
Location – Gurgaon, Haryana, IN

Job description

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com

Position: Quality Engineer (Reliability)

1.1 Job Title: Quality Engineer

Purpose

Actively contribute towards complaints handling and complaints investigations. Interfaces with divisional counterparts in the US and elsewhere to work on Ops deliverables. Work with divisional counterparts to establish the communication plan with different departments, follow-up with stakeholders to complete the project within timelines, resolve any pending issues.

1.2 Reports to: Associate Manager – Quality Assurance

1.3 Roles and Responsibilities

• Interface with health care providers, sales representatives, and patients regarding complaint investigations.
• Complete complaint investigation templates.
• Perform preliminary analysis of complaint investigation devices.
• Generate and analyze metrics and make recommendations as required to Quality Engineers.
• Generate data for Competent Authorities (FDA, BSI, and other regulatory bodies).
• Assist Quality Engineers with tasks related to complain investigations.
• Learn existing product portfolio and business procedures.
• Should be able to document, review, evaluate and investigate responses to product complaints
• Ensures timely investigation of and response to product complaints. This involves initiating and participating in investigations and corrective action arising from product complaints.
• Perform preliminary analysis and data gathering for complaint investigations. Input data into investigation templates and complaint database.

SUPERVISORY RESPONSIBILITY:

• N/A.

Technical Skill Set

Required:

• Good analytical and problem-solving skills.
• Knowledge of DFMEA/PFMEA/Control plan/7QC tools.
• 2-3 years of relevant work experience.
• Proficient computer skills in Excel and Word.

Preferred:

• 4D problem-solving methodology.
• Experience is 7 QC tools – Fish Bone Diagram, Pareto Charts, and Root Cause Analysis.
• Good understanding of database management of complaint records.
• Prior experience using complaints processing software
• Demonstrated problem-solving and troubleshooting skills.
• Demonstrated verbal and written communication skills.
• Demonstrated multitasking and organizational skills.
• Demonstrated knowledge of Microsoft Office (Word, Excel)

Soft Skills:-

• Demonstrated verbal and written communication skills.

Additional

• Excellent analytical skills.
• Effective interpersonal communications skills.
• Blueprint/Engineering schematic reading and interpretation.
• Basic PC skills.
• US FDA quality regulations 21CFR part 820
• ISO 13485 standards
• NC/CAPA process
• Trackwise and windchill knowledge

1.4 Desired Profile

• Education – Bachelors in Mechanical/Biomedical/Biotech Engineering.
• Experience: Experience: 1-3 + years

1.5 Additional Information

Division: Stryker Joint Replacement
Location: Gurgaon/India

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