Welcome to Hologic, where we are dedicated to improving and saving lives through innovative diagnostic solutions. We are currently seeking a highly skilled and detail-oriented Clinical QA Specialist to join our team. As a Clinical QA Specialist, you will play a crucial role in ensuring the quality and accuracy of our clinical products. With your expertise and meticulous approach, you will contribute to the success and growth of our company. If you have a strong background in quality assurance and a passion for making a difference in the healthcare industry, we encourage you to apply.
- Conduct quality assurance checks on all clinical products to ensure accuracy, compliance, and adherence to regulatory standards.
- Develop and implement quality control protocols and procedures to maintain high standards of product quality.
- Collaborate with cross-functional teams including R&D, clinical affairs, and regulatory to identify and resolve quality issues.
- Review and analyze data from clinical trials and investigations to identify trends and potential areas for improvement.
- Participate in the design and implementation of new clinical products, ensuring quality standards are met throughout the development process.
- Conduct audits and inspections of clinical processes and documentation to ensure compliance with internal and external standards.
- Communicate and report on quality metrics and issues to management and other relevant stakeholders.
- Train and educate team members on quality assurance protocols and procedures.
- Stay updated on industry regulations and standards related to clinical products and make recommendations for process improvements.
- Identify and implement best practices for quality assurance processes and procedures.
- Collaborate with suppliers and vendors to ensure quality standards are met for all materials and components used in clinical products.
- Maintain accurate and detailed records of all quality assurance activities.
- Stay current with industry developments and advancements in quality assurance techniques and tools.
- Participate in continuous improvement initiatives to enhance the overall quality of clinical products and processes.
- Maintain a strong commitment to patient safety and the company's mission of improving and saving lives through innovative diagnostic solutions.
Bachelor's Degree In A Related Field Such As Biology, Chemistry, Or Healthcare Administration.
Minimum Of 3-5 Years Of Experience In Clinical Quality Assurance Within The Medical Device Or Biotechnology Industry.
Strong Understanding Of Fda Regulations And Guidelines, Including Iso 13485 And Cgmp.
Experience With Conducting Quality Audits, Developing Quality Systems, And Implementing Corrective And Preventative Actions.
Excellent Communication And Organizational Skills, With The Ability To Work Independently And Collaboratively With Cross-Functional Teams.
Quality Assurance
Process Improvement
Data Analysis
Quality Control
Root Cause Analysis
Compliance Management
Risk assessment
Document Review
Audit Procedures
Regulatory Standards
Training And Education
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
Interpersonal Skills
creativity
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Clinical QA Specialist in Newark, DE, USA is $70,000 to $95,000 per year. This can vary depending on factors such as experience, qualifications, and the specific company or organization the specialist works for.
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Hologic is a global champion of women’s health, we integrate The Science of Sure into everything we do to help improve and save lives through early detection and proactive treatment.
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