
Product Excellence Specialist
4 days ago
As a Quality Professional, you will play a pivotal role in driving improvement and excellence in healthcare. You will have the opportunity to tap into your curiosity and collaborate with innovative minds from around the world.
Your primary objective will be to initiate and perform defined quality activities leading to new or improved processes or systems. This will involve:
- Driving process improvements through updates of risk documentation, procedural changes, test methods, and process/software validation.
- Initiating, reviewing, and approving change controls.
- Performing, analyzing, and interpreting statistical data using an understanding of statistical tools and methods.
- Developing strategies and implementing appropriate sampling methods.
- Ensuring compliance is maintained for product manufacturing, packaging, and labeling.
- Supporting internal and supplier audits.
- Participating in external regulatory body audits.
Key Responsibilities Include:
- Quality Process Improvements
- Change Control Management
- Statistical Data Analysis
- Sampling Methodology
- Regulatory Compliance
- Audit Support
Requirements:
- Education: Degree in Engineering or Science-related field.
- Experience: Three years' experience working in regulated environments, preferably in medical device, FDA, or ISO 13485 registered work environments.
Preferred Qualifications:
- Strong computer skills (MS Excel, PowerPoint, Word).
- Familiarity with statistical tools such as Pareto charts and trend charts.
- Familiarity with FMEA's (Failure Mode and Effects Analysis) and root cause analysis tools.
- Problem-solving techniques.
- Effective communication of technical information.
Benefits:
- Opportunity to drive improvement and excellence in healthcare.
- Collaborative environment with innovative minds.
- Autonomous work setting.
Additional Information:
- Compliance with all relevant training and adherence to associated documentation.
- Adherence to Environmental, Health, and Safety Policies and documentation.
This role offers a unique blend of challenge, growth opportunities, and collaboration with like-minded professionals. If you are passionate about delivering high-quality results and driving process improvements, we encourage you to apply for this exciting opportunity.
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