Advanced Quality Assurance Professional
2 weeks ago
Job Title: Quality Assurance Specialist
">This is a quality assurance specialist position that plays a pivotal role in ensuring our products meet the highest standards of quality, safety, and regulatory compliance.
">Main Responsibilities:
">- ">
- Implementing and maintaining a comprehensive quality management system (QMS) to guarantee adherence to established protocols.">
- Evaluating and enforcing regulatory compliance by identifying, interpreting, and adhering to relevant medical device regulations.">
- Overseeing documentation management, including technical files, regulatory submissions, and internal procedures.">
- Providing quality assurance/ regulatory affairs input and support for design and development activities.">
- Participating in risk management activities throughout the product life cycle.">
- Monitoring device performance in the market and investigating customer complaints.">
- Spearheading supplier quality and compliance management initiatives.">
- Conducting regular internal audits and leading process improvement initiatives.">
Requirements:
">- ">
- Demonstrated expertise in regulatory matters with deep knowledge of global medical device regulations and standards.">
- Strong problem-solving and attention to detail skills.">
- Effective communication skills for coordination with internal departments and external stakeholders.">
- Bachelor's degree in a relevant field, such as engineering, life sciences, or a related technical discipline.">
- Prior experience in QA/RA within the medical device industry is an asset.">
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