BioTouch · 8 hours ago
Quality Manager Job
Columbus, GA
Contract
Onsite
Mid, Senior Level
3+ years expBioTouch is a company focused on quality operations, and they are seeking a Quality Manager to oversee day-to-day quality processes at their Georgia facilities. The role involves ensuring compliance with customer requirements and internal policies while leading the Quality team to improve performance and efficiency.
Logistics
Responsibilities
Lead, coach and develop all personnel within the Quality team to continually improve quality performance, and manufacturing efficiency
Proactively evaluates existing and emerging quality requirements and directs implementation of activities to assure compliance to ISO, and FDA
Lead the maintenance and enhancement of the overall Quality Management System (QMS)
Oversee Supplier Management Program, including distributors
Ensure internal audits are completed, be a part of the internal audit team, conducts audits
Assist in maintaining quality metrics appropriate for Management Review and Monthly Metric reviews
Maintain systems and documentation required for the maintenance of a 21 CFR Part 820 total quality system and compliance to applicable International standards, such as ISO 13485 as required
Lead QMS programs (SCAR, NC, CAPA, Complaints), initiate and direct corrective actions to problems relating to product or process quality, such as complaint resolution, customer interface, regulatory action
This position requires travel to a sister site close by
Other duties as assigned
Qualification
Required
Degree in business, science, or engineering and minimum 3 years prior experience in a leadership Quality Assurance role for a regulated industry: Medical Device, Pharma, 3PL, Food
5 years' minimum leadership experience in Quality Assurance in Medical Device, Pharma, 3PL
Experience working with contract manufacturers, suppliers, or distributors
Exceptional written and oral communication skills
Track record of improving processes and goal achievement
Proficiency in Microsoft Office
Experience with ISO and FDA regulations
Experience in quality management systems
Experience in quality system audits
Desire to own decisions and take responsibility for outcomes
Willingness to continually embrace personal and professional development
All prospective employees must pass a background and drug check
Company
BioTouch
BioTouch is a provider that offers a higher level of care in healthcare delivery.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Steve Jensen
Chief Technology Officer
Paul Mauerman
Chief Financial Officer
Company data provided by crunchbase