What are the responsibilities and job description for the Regulatory Compliance Specialist position at Lincotek Medical?
Job Description
Lincotek Medical is seeking a highly experienced Regulatory Compliance Specialist to join our Quality Assurance Department. As a key member of our team, you will be responsible for managing our product assurance program to ensure the prevention or elimination of defects in new or existing products. This includes ensuring awareness of regulatory and customer requirements throughout the organization.
You will be accountable for the tactical operations of the Quality Assurance Department, including personnel management, team core culture establishment, and collaboration with all manufacturing, finance, supply chain, and EHS departments. Additionally, you will manage all aspects of our company quality system, direct regulatory/ISO compliance, document control, and support staff management.
Key Responsibilities:
Lincotek Medical is seeking a highly experienced Regulatory Compliance Specialist to join our Quality Assurance Department. As a key member of our team, you will be responsible for managing our product assurance program to ensure the prevention or elimination of defects in new or existing products. This includes ensuring awareness of regulatory and customer requirements throughout the organization.
You will be accountable for the tactical operations of the Quality Assurance Department, including personnel management, team core culture establishment, and collaboration with all manufacturing, finance, supply chain, and EHS departments. Additionally, you will manage all aspects of our company quality system, direct regulatory/ISO compliance, document control, and support staff management.
Key Responsibilities:
- Confers with representatives of material and component vendors to obtain information related to supply quality, capacity of vendor to meet orders, and vendor quality standards.
- Directly supervises members of the Quality Department, including interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; addressing complaints and resolving problems.
