Sr QA Manager, Distribution & Warehouse
About The Position
In this role you are responsible for orchestrating operational objectives and plans, monitoring KPIs, resolving complex quality assurance issues, managing supplier processes, overseeing product recalls, maintaining supplier quality, and leading talent management within the organization to drive productivity and alignment with company goals. Your role implements quality assurance policies and strategies to determine methods, techniques, and evaluation criteria in quality assurance, ensuring alignment with organizational objectives for optimal outcomes. Manages talent across the quality assurance team, while driving employee selection, performance management, compensation management, career development, and ensuring effective operational management. Partner with Supplier Quality Assurance for the establishment and oversight of third party contracted warehouses, inspection plan set up, incoming inspection requirements. Reviews and monitors operational key performance indicators (KPIs) to evaluate the success of operations, actively participates in the development, modification, and execution of company policies impacting immediate operations, with potential implications across the organization. Utilizes wide-ranging experience and professional expertise, creatively resolves complex issues aligned with company objectives, distinguished by additional specialized knowledge and recognized as an expert in the field. Guides the review and approval of finished products manufactured for and by the company, manages all inspections and inquiries regarding the operation of manufacturing sites and collaborates with relevant company groups to ensure compliance with company standards, regulations and approved manufacturing process specifications. Leads external and internal audits, aids in regulatory compliance gap closure. Support new, integration, and transfer projects while assuring regulatory compliance and FDA readiness for distribution and warehouse facilities. Leads external and internal audits, aids in regulatory compliance gap closure.
Requirements
- Bachelor's / Master's Degree in Quality Management, Supply Chain Management, Engineering, Science or equivalent.
- 5+ years of experience with Bachelor's in areas such as Medical Device, Quality Assurance, Quality Control, Quality Audit, Compliance Coordination or Warehouse Operations or equivalent.
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
Nice To Haves
- 5+ years of experience with medical device regulations and standards
- Leadership
- QMS Management
- Quality Audits
- CAPA
- Root Cause Analysis
- Data Analysis
Responsibilities
- Orchestrating operational objectives and plans
- Monitoring KPIs
- Resolving complex quality assurance issues
- Managing supplier processes
- Overseeing product recalls
- Maintaining supplier quality
- Leading talent management
- Implementing quality assurance policies and strategies
- Managing talent across the quality assurance team
- Driving employee selection, performance management, compensation management, career development
- Ensuring effective operational management
- Partnering with Supplier Quality Assurance for the establishment and oversight of third party contracted warehouses, inspection plan set up, incoming inspection requirements
- Reviewing and monitoring operational key performance indicators (KPIs)
- Actively participating in the development, modification, and execution of company policies impacting immediate operations
- Creatively resolving complex issues aligned with company objectives
- Guiding the review and approval of finished products manufactured for and by the company
- Managing all inspections and inquiries regarding the operation of manufacturing sites
- Collaborating with relevant company groups to ensure compliance with company standards, regulations and approved manufacturing process specifications
- Leading external and internal audits
- Aiding in regulatory compliance gap closure
- Supporting new, integration, and transfer projects while assuring regulatory compliance and FDA readiness for distribution and warehouse facilities
Benefits
- Generous PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- Stock purchase plan
- Education reimbursement
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What This Job Offers
Job Type
Full-time
Career Level
Senior
