Job Description
Position Summary
Responsible for supporting the quality operations of in-process and finished product and maintaining processes and methods in accordance with the company standards. Reporting on the performance of the assigned quality areas. GMP and ISO compliance.
Key Accountabilities:
· Identifies, Reports and Monitors Nonconforming events for the Receiving Inspection, Clean Room, Final Packaging and Release areas
· Performs product failure investigations and implements corrective and preventive actions to prevent reoccurrence
· Interacts with cross-functional teams to resolve quality issues
· Quality Control, product release authorizations, and quarantine of all suspect or discrepant product.
· Develops Quality Instructions and Quality Standards.
· Support in the development, validation and implementation of Test Methods.
· Reviews and approves engineering changes to support product life cycle.
· Provides adequate QA support to the assigned areas and responds to Internal Audits, and takes actions as appropriate based on CAPAs, Complaints investigations, Nonconforming events, etc.
· Supports the Corrective and Preventive Action (CAPA) System.
· Identifies and evaluates fundamental compliance issues for major functional areas through assessment of quality system compliance.
· Establishes Quality Assurance objectives and assignments, and delegates assignments to subordinates.
· Involved in executing company policies.
· Recommends decisions on administrative or operational matters and ensures Quality Assurance(s) effective achievement of objectives.
Budget managed (if applicable) NA
Internal Networking/Key relationships
This position requires cooperating with different company departments, such as Customer Service, Regulatory, Operations, Logistics, R&D Engineering and the other team members of the department.
Minimum Skills & Capabilities:
· Works with all levels within the company.
· Strong communication skills (written and oral)
· Ability to organize and conduct multiple, parallel tasks
· Ability to seek and utilize varied resources
· Ability to influence others
Minimum Knowledge & Experience required for the position:
· A Bachelor’s degree or equivalent experience in Engineering, Quality Engineering or Sciences.
· Understanding of medical device design and process controls per FDA Quality System Requirements (QSRs) and ISO 13485.
· Understanding of required standards / regulations impacting Medical Devices.
· Leadership ability and organizational skills.
· Strong team oriented professional with good interpersonal skills who is hands-on with a high energy approach to work.
· 5+ years of related experience in a regulated environment in Quality Assurance and or Manufacturing/ Engineering environment.
· Must have experience handling nonconforming events
· Packaging/Labeling process experience is a plus
· SAP knowledge is a plus