Senior Quality Assurance Engineer
hace 2 días
- Revision/analysis of the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques, and other tools and improvement programs.
- Performs benchmarking to develop more effective methods to improve quality.
- Supports the development of quality engineering and compliance of the quality with the adequate abilities for the introduction of new products, and management of the life cycle of the product.
- Revises and approves engineering change orders (ECOs).
- Compliance/Regulatory: Revises/analyzes if the current products and processes (including taken actions or decisions) comply with the regulations, such as QSRs, ISO 13485, etc., including providing support during internal and external audits.
- Participates in the preparations activities for/or interactions with regulatory agencies (FDA, JJRC, BSI, etc.).
- Responds to internal or external audit observations related to the quality engineering function.
- Properly establishes and maintains the required documentation of quality assurance activities and/or quality systems.
- Performs periodical audits to the line to evaluate GMPs, production controls, lot segregation, and process audit according to JJPS. Checks the audit results of the area to ensure that the corrective and preventive actions are adequate.
- New products/process introduction: Works with NPI and with the manufacturing, process engineering, and manufacturing engineering departments to develop, conduct, and approve validation. New Products/Process Introduction: Works with NPI and with the manufacturing, process engineering, and manufacturing engineering departments to develop, conduct, and approve product and process validation strategies of products and processes.
- Product Quality, Control, and Disposition and Performance Standards: Directs and attends to 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. Escalation of quality problems when applicable.
- Provides support in the analysis of products related to customer complaints, to determine failure modes.
- Analyze/check the effectiveness of preventive and corrective actions.
- Defines sampling plans and approves inspection methods for evaluation and acceptance of components and finished product.
- Provides support in the resolution of complex problems (technical).
- Advanced knowledge in specialized fields.
- Wide and diverse knowledge of engineering principles and practices.
- Ability to coordinate and direct personnel activities of technical support.
- Ability to use quality engineering tools and practices.
- Ability to use quality engineering principles and investigation skills and problem resolution.
- Ability to support the business processes and ensure compliance with all applicable federal, state, and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines.
- Opportunity to work with a global healthcare company.
- Chance to develop and improve quality engineering skills.
- Collaborative and dynamic work environment.
- Competitive salary and benefits package.
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