Are you looking for an exciting opportunity to be a part of a global leader in the medical device industry? Stryker is seeking a Quality Engineer FGO QMS to join our team and help us maintain our high standards of quality. As a Quality Engineer, you will play a crucial role in ensuring that our products meet regulatory requirements and exceed customer expectations. If you have a passion for quality and a drive for continuous improvement, read on to learn more about this exciting position and see if you meet our qualifications.
- Develop and maintain a deep understanding of applicable regulatory requirements and standards for medical devices.
- Collaborate with cross-functional teams to ensure that all products meet quality standards and comply with regulatory requirements.
- Conduct risk assessments and develop risk mitigation strategies to ensure product safety and efficacy.
- Participate in design and process changes, providing guidance and ensuring compliance with quality standards.
- Perform root cause analysis and implement corrective and preventive actions to address quality issues.
- Monitor and analyze product and process data to identify trends and areas for improvement.
- Develop and maintain quality documentation, including procedures, work instructions, and reports.
- Conduct audits of internal processes and external suppliers to ensure compliance with quality standards.
- Communicate with customers to address quality concerns and provide timely and effective resolutions.
- Train and mentor team members on quality procedures and best practices.
- Continuously review and improve quality systems and processes to drive efficiency and effectiveness.
- Act as a subject matter expert for quality-related inquiries and provide guidance on quality-related matters to the organization.
- Stay up-to-date with industry developments and advancements in quality standards and regulations.
- Promote a culture of quality and continuous improvement throughout the organization.
- Represent the company in external audits and regulatory inspections, ensuring compliance and timely resolution of any findings.
Bachelor's Degree In Engineering Or Related Field: A Quality Engineer Fgo Qms At Stryker Should Have A Strong Educational Background In Engineering Or A Related Field. This Will Provide The Necessary Technical Knowledge And Skills To Effectively Manage Quality Systems And Processes.
Quality Management System Experience: Stryker Is A Medical Technology Company That Adheres To Strict Quality Standards. Therefore, A Quality Engineer Fgo Qms Should Have Experience Working With Quality Management Systems, Such As Iso 13485, Fda Regulations, And Other Relevant Standards.
Strong Analytical And Problem-Solving Skills: Quality Engineers At Stryker Are Responsible For Identifying And Resolving Quality Issues And Implementing Corrective Actions. Having Strong Analytical And Problem-Solving Skills Is Essential To Effectively Manage And Improve The Quality Management System.
Excellent Communication And Interpersonal Skills: A Quality Engineer Fgo Qms At Stryker Will Be Working With Cross-Functional Teams, Including Engineers, Suppliers, And Manufacturing Personnel. Therefore, Excellent Communication And Interpersonal Skills Are Crucial To Collaborate And Communicate Effectively With Team Members.
Attention To Detail And Accuracy: In The Medical Technology Industry, Attention To Detail And Accuracy Are Critical For Ensuring The Safety And Effectiveness Of Products. A Quality Engineer Fgo Qms At Stryker Should Have A Keen Eye For Detail And A Commitment To Maintaining High Levels Of Accuracy In All Quality-Related Tasks And Processes.
Process Improvement
Quality Management
statistical analysis
Root Cause Analysis
Risk Analysis
Change control
Regulatory compliance
Supplier management
Documentation control
Quality Auditing
Validation/Verification
Communication
Conflict Resolution
Leadership
Time management
creativity
Organization
Critical thinking
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Quality Engineer FGO QMS in Warsaw, Poland is between 6,000 PLN to 12,000 PLN per month. This equates to approximately $1,600 USD to $3,200 USD per month. However, this may vary depending on the specific company, experience level, and other factors.
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Stryker Corp. is engaged in providing medical technology products and services. It operates through the following segments: Orthopaedics, MedSurg and Neurotechnology and Spine. The Orthopaedics segment provides reconstructive and trauma implant systems. The Medsurg segment deals with surgical instruments and equipment, endoscopy, patient handling, and reprocessed medical devices. The Neurotechnology and Spine segment pertains to spinal implants and neurovascular products.
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