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- Mount Vernon, NY
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Senior Quality Engineer
MR-MRI-North Naples • Mount Vernon, NY
Posted 1 month ago
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Growing Medical Device Client is seeking an Engineer with significant upside to join their quality team. The Sr. Manufacturing Quality Engineer is responsible for the quality assurance of all products, quality system management, and manufacturing process quality and customer problem resolution. The MQE is also responsible for supporting continuous improvement activities and all results related to product quality, performance and safety. This position reports directly into the Director of Quality.
Primary Duties and Responsibilities include:
- Provides quality engineering support to manufacturing and product development groups. Works closely with Operations and R&D to develop and implement appropriate risk management, qualification, verification and validation plans
- Assesses, provides recommendations, and leads implementation of systems, processes and equipment for improvement and compliance to cGMP and current ISO 13485 within the Manufacturing & Operations, R&D, Quality and Regulatory processes to ensure safe and effective products are produced. Provides written reports and supporting documentation for recommendations
- Supports company goals and objectives, policies and procedures in compliance with quality systems, FDA regulations and MDD requirements
- Serves as a technical resource to support quality initiatives and objectives for assigned Value Stream and other manufacturing teams.
- Supports the CAPA process, collaborating with owners to ensure effective root cause analysis and the development of innovative, long-term solutions
- Leads problem solving efforts to identify and resolve recurring and new quality issues to ensure production of safe and effective medical devices
- Tracks effectiveness of corrective action plans and compliance improvement initiatives
- Develops and implements quality control process sampling systems, procedures, and statistical techniques
- Responsible for supporting the quality control functions which may include assisting with sampling plans, supplier development, and quality training
- Ensures accurate project schedules are maintained and communicated to both internal and external management
- Prepares and reviews qualification and validation test plans and reports for assigned projects, including, if required, reliability assessments. Assures the resolution of issues raised by the testing
- Performs machine and process capability and performance studies; recommends and upon approval, implements changes and upgrades to systems, procedures or processes to improve product quality
- Maintain Internal Audit program per ISO 13485/FDA Part 820
- Internal Audits, Customer Audits, and ISO/TS Audits
- Responsible for planning, organizing, directing, and reporting on all Supplier Quality activities and performing Supplier Quality Audits
- BS in Engineering highly preferred – other science based technical degrees will be considered
- Minimum of 5 years of Quality experience supporting Manufacturing Operations
- MUST have thorough understanding of Good Manufacturing Practices, Quality Systems, Regulatory Requirements, Validation Principles and Manufacturing Methods in a Medical Device regulated environment
- FDA/ISO/TS quality system knowledge and experience necessary (any or all)
- Understanding of inputs, outputs, raw materials, waste, quality control, costs, and techniques for maximizing the manufacture and distribution of goods
- Strong project management skills as well as an ability to multi-task
- Must be able to read, analyze and interpret common scientific and technical journals, and legal documents; write reports, business correspondence and procedure manuals; as well as respond to common inquires or complaints from customers, regulatory agencies, or members of the business community. Must be able to effectively present information to top management, public groups and /or boards of directors
- ASQ certified Quality Auditor and/or Quality Engineer, PE and/or Lean Six Sigma Certifications are highly desirable