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Senior Quality Assurance Specialist
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Job Title: Senior Quality Engineer
About the Role:
We are seeking a highly skilled Senior Quality Engineer to join our team at Johnson & Johnson Medical Devices Companies. As a Senior Quality Engineer, you will play a critical role in ensuring the quality and compliance of our medical devices.
Key Responsibilities:
- Develop and implement quality-engineered systems and products to meet regulatory requirements.
- Lead and support design verification tests, process validations, and quality processes to ensure compliance with company policies and procedures.
- Collaborate with cross-functional teams to identify and implement quality improvement opportunities.
- Develop and establish effective quality control and risk management plans.
- Write, review, and approve process and product validation protocols and reports.
- Analyze data using statistical tools to make acceptance decisions and improve process capability.
- Ensure development activities follow design control requirements and product testing meets applicable standards.
- Support vendor audits and Supplier Quality as a Quality representative.
- Initiate and investigate Corrective and Preventative Actions (CAPA).
- Assist in complaint analysis and Regulatory Affairs submissions.
- Participate in design reviews and pre-validation assessments.
- Supervise and provide guidance to Inspectors and Technicians in Quality activities.
- Communicate business-related issues or opportunities to management.
- Ensure compliance with all health, safety, and environmental practices.
Requirements:
Bachelor's degree in a related field, along with a minimum of 4 – 6 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry is required. Master's degree is preferred.
American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable.
Thorough knowledge of Quality systems, processes, and regulations for medical devices.
Ability to train and mentor employees on quality topics.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
