Quality Assurance Specialist

Job Summary

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

Essential Duties and Responsibilities

As the Quality Assurance Principal, this position will: 

• Actively 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. 

• Act as the Quality 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 Quality Assurance team members to ensure consistent implementation of Quality processes, including design control and risk management. 

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

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

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

• Participate in the development of junior staff, as requested 

• Collect/monitor quality 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 Quality 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 pre- 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 able 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.