Therakos Healthcare Limited ยท 13 hours ago
Quality Engineering Manager
Nashville, TN
Full-time
Onsite
Director/Executive
10+ years expTherakos Healthcare Limited is seeking a Quality Engineering Manager to oversee quality engineering for medical device products and manufacturing processes. The role involves managing quality engineers, ensuring compliance, and leading process excellence activities.
Pharmaceuticals
Hiring Manager
Michelle Keller
Responsibilities
Provide Quality leadership for design control and development activities for new products and design changes
Serve as subject matter expert to Quality, R&D, and CMOs to lead and mentor design teams on Six Sigma techniques to be used during development and design changes (statistical sample plans, Gage R&R, DOE, process capability, reliability analysis, tolerance stack up, etc)
Author and assist in providing design control deliverables to ensure development phase requirements are documented and compliant
Facilitate Six Sigma training for internal departments and external (CMOs)
Lead risk management (Hazard Analysis, FMEA) activities for new product design and current product design changes
Collaborate in development of verification and validation plans and reports
Lead root cause analysis investigations on medical device products in conjunction with CMOs. Work with CMOs to identify and implement appropriate corrective actions to eliminate current problems and prevent future problems
Serve as Quality Representative for change control, quality events, CAPAs, and audit records in eQMS. Work with external CMOs to resolve technical issues as needed
Serve as SME for internal audits and regulatory inspections
Qualification
Required
Excellent communication, presentation, time management, cross-functional collaboration skills
Attention to detail
Multi-tasking
Experience in medical devices
Strong computer skills (Word, Excel, PowerPoint, Minitab)
Extensive experience in Quality with respect to manufacturing and design
Validation
Design Control
Data Analysis and Statistical Techniques
Investigations and Root Cause Analysis
CAPA and NC
Lean Six Sigma tools
10+ years in a similar role in cGMP, medical device, or regulated industry (including QA or engineering experience)
Management/mentorship of personnel
BS in Science, Engineering, or equivalent combination of Education, Experience and Competencies
Preferred
MS in Science, Engineering, or other related discipline
Certified Six Sigma Blackbelt
ASQ Certified Quality Engineer
Benefits
Competitive salary and benefits package.
Opportunities for professional development and career growth.
Collaborative and innovative work environment.
Company
Therakos Healthcare Limited
Please visit our regional websites for product information.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase