Manager, Quality Systems
Core
Manage site Quality function, products, and processes to meet quality and regulatory requirements for medical devices.
Role type
Manager, Quality Systems
Builds
compliant medical device products and services
Domain
Life Sciences / Medical Devices / Regulated Industry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Engineering, Quality Assurance, Quality Systems, Supplier Quality, Regulatory Compliance, CAPA, risk analysis, FMEA, root cause analysis, internal/external audit leadership, team mentorship, continuous improvement methodologies, data analysis, project management
Preferred skills
Chemistry, Biology, Engineering, Pharmacy, Lean, Six Sigma
Technologies
ISO 9001, ISO 13485, FDA QSR/cGMP
Responsibilities
Manage site Quality function in overall systems, products and processes to meet quality and relevant regulatory requirements as they pertain to CMD; Work with cross function team to ensure timely investigation of nonconformance / customer complaints and the implementation of effective corrective actions; Perform inspection of the returned materials and provide dispositions; Oversee applicable inspection processes; Support Customer, Regulatory and Corporate Audits; Ensure quality activities are in alignment with company goals, objectives and in compliance with QMS; Responsible for and acts as the Management Representative during any external audits where CMD requires representation; Responsible for the inspection and product testing procedures to ensure consistent methods throughout the facility; Assure that issues potentially affecting product quality/compliance are brought to the attention of Senior Management
Seniority
Manager, hands-on leadership
