Quality Assurance Engineer II
2 weeks ago
Quality Assurance Engineer II
Overview
At J&J Family of Companies, we are seeking a Quality Assurance Engineer II to join our team. This role is essential in ensuring the highest standards of quality in our manufacturing processes.
Company Mission
We are committed to advancing healthcare innovation, enabling us to tackle complex health challenges and improve patient outcomes. Our dedication to diversity, equity, and inclusion is fundamental to our culture and drives our success in delivering impactful healthcare solutions.
Role Responsibilities:
- Provide comprehensive quality assurance oversight for manufacturing operations, ensuring compliance with good manufacturing practices and relevant international standards.
- Support daily manufacturing activities by reviewing nonconformances, conducting process validations, and performing risk assessments.
- Lead initiatives to enhance understanding of quality regulations, representing the quality function during audits.
- Facilitate effective communication across various departments, including Research & Development, Regulatory Affairs, and Manufacturing.
- Develop and implement measurement systems to assess the effectiveness of quality and reliability processes, driving continuous improvement.
- Contribute to the enhancement of the Quality Management System to align with compliance and business objectives.
Qualifications
Education:
- A Bachelor's degree or equivalent is required.
Experience and Skills:
Required:
- 0-2 years of relevant experience in the medical device or regulated industry.
- Strong skills in communication, teamwork, problem-solving, and decision-making.
- Familiarity with root cause analysis methodologies.
Preferred:
- Knowledge of FDA regulations, ISO 13485, and other relevant standards.
- Experience with design and testing for medical safety standards.
- Proficiency in Test Method Validation.
- Certifications in Six Sigma, Lean, or ASQ are advantageous.
Additional Information:
- This position may require occasional travel.
- Flexibility to support different shifts may be necessary.
We are an Equal Opportunity Employer, committed to fostering a diverse and inclusive workplace.
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