Top Quality Management Executive - Healthcare jobs in Asheville, NC

· Responsible for all aspects of the Quality Department in Mills River

· Management representative

· Compliance with and enforcement of all procedures and practices relating to FDA regulations and ISO 13485 requirements

· Manager for all Quality Department staff

· Oversee Product Label printing and reconciliation

· Prepare and Manage updates to Site Quality System Procedures

· Administer Customer Complaint Program including performing investigations and documentation reviews

· Administer Corrective and Preventive Action Program

· Administer Non-Conforming Product Program including material disposition

· Manage, Schedule and Perform Internal Audits

· Manage, Schedule and Perform Supplier Audits

· Manage and support site for Customer Audits

· Schedule and perform quarterly microbiological studies in clean rooms

· Prepare and route Quarterly Environmental Report for Particulate and Bioburden

· Responsibility for strict observance of legal rules and regulations referring to work safety and adherence of working time

· Exhibit Leadership principals, leading Staff to the expectations of RAUMEDIC and the Guidelines of RAUMEDIC

· Monitoring the effectiveness of quality system in the plant

· Report on Goals and Key Operating Indicators

· Final Release of all products for shipment

· Provide input and support to develop, review, initiate and update Failure Mode Effect Analysis

· Prepare and Manage updates to Site Quality System Procedures

· Interface with Customer on Technical/Quality Issues and improvements in cooperation of the Business Unit

· Responsible for all Site Regulatory items

· Direct oversight of all metrology functions for production and new product validation

· Direct oversight of preparation of all documents required for Validations (Protocols and Reports)

· Schedule and perform training activities for all staff on required procedures

· Maintain all Training Records for Staff

· Act as a backup for all Quality Functions (QE, Documentation, Technician, QC Inspector)

· Additional duties as required

Job Type: Full-time

Pay: $120,000.00 - $160,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• In-person
• Manufacturing facility

Ability to Relocate:

• Mills River, NC 28759: Relocate before starting work (Required)

Work Location: In person