Quality Auditing / Systems Specialist 3
12 Months
Franklin Lakes NJ 07417

Must have

• Ability to perform multiple tasks simultaneously and prioritize workload with minimum supervision
• At least 3-5 years of medical device, biologic, pharmaceutical, or diagnostic industry experience.
• Collaborative ability to work with diverse cross-functional teams
• Effective analytical, technical, and problem-solving skills.
• Proficient communication, organizational and interpersonal skills.

Nice to Have

• Audit experience is desirable.
• Knowledge of US and International regulations and standards that apply to the medical device industry, such as 21CFR820, ISO 13485, EU MDR, and MDSAP is highly desirable.

Job Description

• The Site Supplier Quality Specialist is responsible for defining and executing the supplier management activities required to approve site and local suppliers and to maintain their approved status through their service lifecycle.
• This is achieved by providing collaborative support to quality leadership and working with other functions in the organization including Quality Engineering, WW Supplier Quality Assurance, Research and Development, Regulatory Affairs, and additionally to corporate functions, regulatory agencies, and suppliers. 
• This position is also accountable for the support of the continued improvement and implementation of the Quality Management System as well as maintaining compliance to regulations, standards, and corporate requirements.

Responsibilities:

• Develop applicable Site / Unit procedures / work instructions and may make updates to Unit level procedures and policies.
• Serve as Supplier Quality associate for local and/or site-related suppliers (products and services)
• Support identification suppliers and collaborate with cross-functional and/or WW team to complete supplier selection process
• Implement supplier approval strategy. Facilitate, manage, and track supplier qualification and approval progress
• Support Supplier creation/updates in Aravo
• Manage and maintain Quality Agreements with suppliers, when needed
• Provide on-going Supplier Quality Assurance support to all existing local and site-related suppliers
• Collect and archive all relevant Supplier-related documentation
• Support Supplier Quality performance monitoring.
• Support and/or conduct supplier quality audits / assessments, as needed.
• Manage changes initiated by suppliers. Coordinate with appropriate cross-functional teams
• Support QA/QC lab with supplier activities related to product batch release and customer complaints as necessary
• Lead or support problem-solving and root cause analysis activities (CAPA, Audits, Nonconformances, customer complaints, Supplier related complaints, etc.), as needed.
• Support internal and external audits as a subject matter expert, and support pre-and post-audit activities, as needed.
• Track trends of various quality data sources. Analyze and report on metrics.
• Support Site and WW Quality continuous improvement initiatives

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 70.00/hr.