Quality Engineer
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Job Location:
Monthly Salary:
Posted on:
3 days ago
Vacancies:
1 Vacancy
Job Summary
Work Flexibility: Hybrid or Onsite
What you will do:
- Independently manage and ensure compliance with the assigned QMS functions in line with of ISO 13485:2016 requirements.
- Management of Site Validation Program including execution and review of Validation activities of equipment Processes Test Method facilities and utilities and computer system
- Handle Deviation Risk Assessments and Out of Calibration Results in accordance with established procedures.
- Review and monitor Preventive maintenance and AMC schedules ensuring timely execution and compliance.
- Coordinate and support Change Managementactivities
- Track Analyze and report on Key Performance Indicators (KPIs) to ensure adherence to processes and prevent non-conformity relating to product process or system.
- Perform data analysis using various statistical tools to support quality decision making.
- Work closely with cross-functional teams to ensure site compliance with QMS requirements.
- Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS.
What you will need:
Required
- Bachelors in engineering or science or Equivalent.
- 2-5 years of relevant experience in QMS or Quality Assurance. Experience in Medical Devices domain is an added advantage.
- Strong understanding of Quality Management Systems preferably ISO 13485 or ISO 9001
- Strong interpersonal skills written verbal communication skills. Basic analytical and problem-solving capabilities.
- Demonstrated ability to work in cross-functional team environments.
- Proficiency in Microsoft Office tools and Adobe Acrobat
Preferred
- Basic knowledge of Quality Systems (CAPA audits Management Review Quality Planning etc.)
- Ability to manage multiple tasks and represent the Quality function across teams.
Required Experience:
IC
Key Skills
- APQP
- Quality Assurance
- Six Sigma
- ISO 9001
- PPAP
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
About Company
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. Alongsid ... View more
