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Senior Quality Assurance Specialist
4 weeks ago
Medline Industries is seeking a highly skilled Senior Quality Engineer to join our team. As a key member of our quality team, you will be responsible for ensuring the highest quality standards in our products and processes.
Key Responsibilities- Develop and implement quality standards and procedures to ensure compliance with regulatory requirements.
- Lead process improvement initiatives to optimize product quality and reduce defects.
- Collaborate with cross-functional teams to design and implement quality control measures.
- Conduct vendor management and qualification to ensure compliance with quality standards.
- Generate and maintain quality documentation, including Device Master Records and CE technical files.
- Bachelor's degree in Engineering, Science, Math, or related technical field.
- At least 4 years of experience in quality or engineering, preferably in medical devices.
- Advanced knowledge of quality assurance codes and standards, including 21 CFR 820 and ISO 13485.
- Excellent problem-solving and leadership skills, with ability to work independently and as part of a team.
- Strong communication and interpersonal skills, with ability to collaborate with cross-functional teams.
- At least 5 years of industry experience in medical devices, drugs, or related fields.
- Knowledge of advanced Six Sigma/Lean concepts.
Medline Industries is a leading manufacturer and distributor of medical and surgical supplies. We are committed to providing high-quality products and services to our customers, and we are seeking a talented and motivated individual to join our team.
