Quality Assurance Specialist for Medical Devices
hace 1 semana
We are seeking a highly skilled Quality Assurance Specialist to join our team at Coloplast, a leading medical device company. This is an exciting opportunity to work in a dynamic and collaborative environment where you will play a key role in ensuring the quality of our products meets the highest standards.
About UsColoplast is a global company with a strong commitment to innovation, customer satisfaction, and quality. Our business includes Ostomy Care, Continence Care, Urology Care, and Wound and Skin Care. We strive to create solutions that meet the specific needs of our customers and improve their quality of life.
Job Description
As a Quality Assurance Specialist, you will be responsible for ensuring compliance with FDA/ISO regulations and maintaining high-quality standards in our production processes. Your duties will include providing quality engineering support to Operations value streams, ensuring compliance with our Quality Management system, recommending and implementing quality improvements, and participating in external and internal audits.
Key Responsibilities:
- Provide quality engineering support to Operations value streams to ensure FDA/ISO compliance.
- Ensure compliance with Coloplast Quality Management system incl. creation, maintenance and execution of SOPs and WIs.
- Recommend and implement quality improvements of products/processes.
- Participate and provide support in external and internal audits.
- Perform RCAs and handle NCs/CAPAs incl. handling of lot status in ERP system.
Requirements:
- Bachelor's degree in Industrial Engineering, Quality, Production, Chemistry or equivalent.
- Minimum 2 years of experience within medical device manufacturing with thorough knowledge of methodologies of quality assurance and standards.
- Able to work to a high level with minimal supervision.
- Able to solve problems independently, take the initiative when required and anticipate needs.
- English B2 level reading, writing, and speaking in a conversational level.
Benefits
We offer a competitive salary of $80,000 - $110,000 per year, depending on your qualifications and experience. Additionally, we provide a comprehensive benefits package, including health insurance, retirement plan, and opportunities for professional growth and development.
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