Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.

• Serves as the Subject Matter Expert (SME) for the training process and the associated electronic systems (SAP PLM and Summit SuccessFactors LMS).
• Responsible for the daily maintenance of the electronic LMS as well as overall compliance of the system to applicable regulations and company SOPs.
• Assign training requirements for new employees, in collaboration with management and HR, providing assistance and troubleshooting issues as needed.
• Works with functional managers and SMEs to develop course content for system training programs as necessary.
• Ensure training curricula and assignments are correct and updated / reviewed regularly to comply with applicable SOPs and requirements.
• Perform group and individual training as needed to drive conformance to the quality system.
• Recommend changes and policies to drive continuous improvement and streamline the document control and training processes.
• Author and revise Quality Documents (e.g. SOPs, forms, guidance documents, etc.) related to quality system processes, as required.
• Compile / analyze / trend monthly and quarterly KPI metrics related to quality processes including but not limited to Document Control;

Training; CAPA; Supplier Quality; NCs; Audit Results; Complaints / Post Market Surveillance. May provide other Quality System metrics depending on business needs.

• Provides audit support (internal, external, 3rd party); may be required to scribe during audits.
• Comply with and reinforce the requirements of the Quality Manual, ISO 13485, 21 CFR 820 FDA Quality System Regulation, MDSAP and other applicable regulatory requirements.
• Demonstrated initiative, commitment, and follow-through with assigned tasks with minimal oversight.
• May include other duties as defined by the QA Manager.
• Embody and deliver the Exceptional Every day.

Qualifications (Select the minimum qualifications required for this position to successfully achieve business requirements)

Education

• Associate’s degree required.
• Education and experience combination :
• Bachelor’s degree is equivalent to three (3) years of experience.

Experience

• 3 to 5 years relevant experience
• Specific Related Experience : Experience within FDA and / or ISO13485 or other regulated industry experience required.

Skills

• Strong working knowledge of SAP and SuccessFactors.
• Use of independent judgment and analysis required.
• Strong attention to detail required.
• Strong MS Office skills are required, including use of Excel for data analysis (pivot tables, V-lookup, etc.).
• Strong interpersonal communication skills are required.

Physical Demands

The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Sit; use hands to finger, handle or feel objects, tools, or controls.
• Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.

Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.