
Senior Quality Assurance Specialist
Are you a highly experienced Quality Assurance professional seeking a new opportunity to utilize your skills and expertise? Look no further! Hologic, a leading global healthcare and diagnostics company, is seeking a Senior Quality Assurance Specialist to join our team. We are looking for an individual who is passionate about ensuring the highest level of quality in our products and processes. If you have a keen eye for detail, a strong understanding of quality systems and regulations, and a desire to work in a dynamic and innovative environment, we encourage you to apply for this exciting role.
- Develop and implement quality assurance policies and procedures to ensure compliance with company standards and regulations.
- Conduct thorough and detailed reviews of product designs, specifications, and manufacturing processes to identify potential quality issues.
- Collaborate with cross-functional teams to identify areas for improvement and implement corrective actions to maintain high levels of quality.
- Lead and support internal and external audits to ensure compliance with regulatory requirements and industry standards.
- Develop and maintain quality metrics to monitor and improve product quality and process efficiency.
- Investigate and document customer complaints and non-conformances, and provide recommendations for corrective actions.
- Provide guidance and training to team members on quality standards, processes, and regulations.
- Stay updated on industry trends and regulations related to quality assurance, and make recommendations for process improvements as needed.
- Establish and maintain relationships with key stakeholders, including suppliers and customers, to ensure quality standards are met throughout the supply chain.
- Monitor and evaluate the effectiveness of quality systems and recommend improvements as necessary.
- Mentor and coach junior team members to develop their skills and knowledge in quality assurance.
- Participate in cross-functional projects and initiatives to drive continuous improvement and promote a culture of quality within the organization.
- Communicate and report on quality metrics and issues to management and other stakeholders.
- Ensure compliance with all safety regulations and company policies.
- Represent the company in external quality audits and inspections.
Minimum Of 5 Years Of Experience In Quality Assurance Within The Medical Device Industry, Preferably In Women's Health Products.
Bachelor's Degree In A Relevant Field Such As Engineering, Biology, Or Chemistry.
In-Depth Knowledge Of Fda Regulations And Iso 13485 Quality Management Systems.
Experience In Leading And Managing A Team Of Quality Assurance Professionals.
Strong Analytical Skills And Attention To Detail, With A Track Record Of Implementing Successful Quality Control Processes.
Process Improvement
Data Analysis
Quality Management
Test Automation
Test Planning
Technical Writing
Root Cause Analysis
Compliance Management
Risk assessment
Agile methodologies
Validation testing
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Senior Quality Assurance Specialist in San Diego, CA, USA is $70,000-$100,000 per year. This can vary depending on the specific industry, company, and level of experience of the individual. Some may earn higher salaries with bonuses and other benefits, while others may earn less.
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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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