Aspen Surgical is a leading worldwide manufacturer of surgical disposable products with an emphasis on safety. Our extensive portfolio of specialty medical products and surgical instruments includes Bard-Parker® Blades and Scalpels, O.R. Accessories, Patient and Staff Safety Products, Wound Care Products, and Instrument Care Products.
Description POSITION OVERVIEW: Individual will be responsible for supporting all aspects of Aspen Surgical's Product Life Cycle Management (PLM), Product Data Management (PDM), Enterprise Resource Planning (ERP) systems to enable best-fit architectural solutions. The Sr. Analyst related tasks are holistic in nature, encompassing full systems implementation lifecycle including requirements gathering/documentation, implementing new applications and enhancements, configuration, testing (unit, system, and integration), user training, issue triage, analyzing and implementing changes, and working with the software vendor to resolve identified software issues. ESSENTIAL DUTIES AND RESPONSIBILITIES: - Other duties may be assigned * Provide specialized technical support to engineers (and others) for effective application usage * Evaluate current system capabilities to identify changes that need to be made and determine the impact to the QMS and overall business * Ensure that workflow programming requirements fulfill quality and business objectives * Establish best practices, technical standards, and guidelines for the effective use and management of the PLM/PDM/ERP environments * Serve as the caretaker of all controlled documents including maintenance of any hardcopy and electronic documents including templates, procedures, drawings, process maps, forms, etc. * Process and coordinate creation, completion, and implementation of change requests and change orders for items such as commercial bill of materials, routings, control plans, product structures, approved suppliers list, supply chain tables, and item creation * Lead regulatory projects related to product attributes including labeling * Communicates to management direction, status, and issues with work assignments through status / trending reports * Supervisory responsibilities may be in the scope of the role * Performs other tasks and duties as assigned by Quality Management Qualifications QUALITY AND REGULATORY REQUIREMENTS: * Knowledge of quality system including the quality manual, quality policy and applicable procedures and work instructions * Establish, implement, and maintain the quality system in accordance to FDA Quality System Regulation, ISO 13485, European Union Medical Device Directives, and Canadian Medical Device Regulations
EDUCATION, EXPERIENCE, QUALIFICATIONS AND SKILLS: * Minimum: high school diploma; Preferred - Associate or Bachelor's degree in technical areas such as Engineering, Engineering Technology, Computer Science, Information Systems, or technology related field
* Experience with PLM, PDM systems in an organization that manufactures high volume, complex products
* Project management, self-management, and multi-tasking skills
* Must have 2+ years of experience in delivering and operationalizing core PLM/PDM/ERP modules (preferably in a regulated industry) * At least 1+ year experience in manufacturing, quality systems, and system administration
* Must be able to solve complex technical problems through research and technical analysis
* Experience with workflow mapping is highly valued
* Strong computer skills and knowledge of MS applications, Word, Excel, Powerpoint, Access
* Solid understanding of Electronic Document Management System & Electronic Change Control Systems
* Must have strong verbal and interpersonal communication skills
* Strong English writing, editing, and grammar skills * Must have a positive attitude while maintaining flexibility
* Note: this role may supervise others. As such, supervisory experience would be highly preferred.
PHYSICAL REQUIREMENTS:
NOTE: The inability to perform any of the following physical requirements does not preclude an applicant from consideration unless, following an individualized analysis, it is determined that the physical requirement is an essential job function and the applicant is unable to perform such function with or without reasonable accommodation
Please refer to the Essential Duties and Responsibilities. Aspen Surgical is an equal employment employer F/M/Disability/Vet/Sexual Orientation/Gender Identity
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Employer's Job# 73412769
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