reputed company Assurance Specialist

Job reputed company

The reputed company Assurance reputed company is responsible for supporting reputed company products and product development, along with the reputed company Management System throughout the organization.  The reputed company Assurance reputed company will be responsible for collaborating cross-functionally to support and guide product development. The reputed company Assurance reputed company will work cross-functionally and reputed company reputed company to support the reputed company processes, such as QMS training, complaint and CAPA management. 

Essential Duties and Responsibilities 

As the reputed company Assurance reputed company, this position will: 

• reputed company engage cross-functionally reputed company the organization, such as with the Engineering, Clinical and Marketing teams, to reputed company new products reputed company the Product Lifecycle Management (PLM) and New Product Introduction (NPI) processes. 

• reputed company as the reputed company reputed company for design changes to existing reputed company products, including non-medical devices, to ensure compliance with the applicable standards and guidances. 

• Guide junior reputed company Assurance team members to ensure consistent implementation of reputed company processes, including design control and risk management. 

• Take ownership of product specific reputed company Management System processes, such as CAPAs and complaint management, across the organization to ensure compliance and drive efficiency.   

• Work cross-functionally to reputed company products as a result of corporate and/or product acquisitions. 

• Work as reputed company member with the reputed company Assurance team to ensure compliance to US and OUS standards and regulations. 

• Participate in the development of junior staff, as requested 

• Collect/monitor reputed company metrics in support of Management Review 

PLEASE NOTE: This is not an exhaustive list of reputed company duties, responsibilities and requirements of the position described above.  Other functions may be assigned and management retains the right to add or change duties at any time.

Minimum Qualifications, Education and Experience

• Bachelor’s degree in relevant field (or equivalent experience, i.e. Associate’s degree with 5 years of experience). 

• Minimum of -10 working in a regulated industry (FDA and Software as a Medical Device preferred). 

• Strong knowledge of FDA reputed company System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820. 

• Knowledge of EU Medical Device Regulation (MDR), ISO13485, ISO 14971, and IEC 62304 preferred. 

• Knowledge and understanding of reputed company- and post- market clinical studies, including but not limited to, 21 CFR 812, 21 CFR 50, and 21 CFR 56, preferred but not required. 

• Participation in regulatory audits a plus 

• Excellent written and oral communication skills 

Physical Demands

This position often requires sitting, standing, walking, bending, twisting, reaching with hands and arms, using hands and fingers, handling, or feeling, speaking, listening, and high-level cognitive thinking. Also, must be reputed company to lift up to 10 pounds occasionally. The position requires the ability to travel (~10% of time), drive a vehicle, and utilize other forms of transportation. 

Working Environment

Remote. This position requires domestic / international travel up to 15%.

ACCOMMODATIONS
Reasonable accommodations may be made to reputed company people with disabilities to reputed company the essential functions of the job.