Senior Quality Manager
hace 3 días
Estimated Salary: $120,000 - $180,000 per year
About the RoleWe are seeking an experienced Senior Quality Engineer to join our team at Johnson & Johnson Sa De Cv in Ciudad Juarez, Mexico. This role is responsible for planning, conducting, and directing engineering projects or studies, including complete projects that require advanced knowledge in specialized fields.
Key Responsibilities:
- Apply quality engineering tools and practices for the effective and efficient development of transfers and the maintenance of products / processes throughout the complete life cycle of the product.
- Use quality engineering principles and investigation skills and problem resolution to improve and maintain the products / processes aligned with quality and the business global vision.
- Support the business processes, revising / analyzing if the current products and processes (including taken actions or decisions) comply with regulations such as QSRs, ISO 13485, etc.
- Participate in preparations activities for/or interactions with regulatory agencies (FDA, JJRC, BSI, etc.).
- Direct and attend NCs Revisions meetings as a member of MRB, conducts and supports investigations, bounding, documentation, revision and approval of the non-conformities (NCs), preventive and corrective actions (CAPAs) and customer complaints.
Requirements:
- Undergraduate degree in Engineering, or related field.
- Minimum 5 years of experience in Quality Engineering, preferably in the pharmaceutical industry.
- Knowledge of FDA regulations, GMPs, and ISO 13485.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
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