The position is responsible to ensure that activities throughout the product lifecycle are compliant with procedures, standards, and regulations applicable to our products.
Requirements
- Working knowledge of domestic and international quality/regulatory standards related to our products
- Knowledge of quality management techniques (Lean, Six Sigma) and statistical techniques required to measure and confirm significant changes.
- Working knowledge of IL products, technology and manufacturing processes including impact on customers and patient requirements.
- Demonstrates judgement commensurate with experience regarding application of regulatory requirements to data review, reports, design changes, risk management, etc. to ensure compliance and achieving business objectives.
- Demonstrated understanding of risk-based approach to processes and decisions.
- Duties necessitate broad and thorough knowledge of engineering and science theory and principles, including R&D, quality control, manufacturing, and design engineering
- Understanding of the application of technical principles and engineering problem solving to resolve complex issues.
Responsibilities
- Participates in the generation and review of quality documents throughout the product lifecycle
- Ensures product quality meets requirements and documentation is complete prior to approval
- Participates on core teams supporting new product development or design changes
- On assigned projects, advises team regarding implementation of Design Control and Product Realization requirements for design, production, and distribution of IL products
- On new product development and or product performance investigations, provides guidance on tools and techniques available
- Provides input on product requirements, acceptance criteria, traceability, process monitoring, product evaluation, failure investigation and complaint analysis.
- Advises regarding application of sound statistical methods and quality tools in the evaluation and documentation of results related to design control, purchased part qualifications, V&V, risk analysis, production transfer, production, distribution and marketing of IL products.
Other
- The position works independently and with guidance from manager develops, applies, and implements methods, tools, and practices to achieve product quality goals and requirements in the areas of design, development, production, distribution, maintenance, and service.
- Advises and directs teams , in coordination with management, regarding compliance to procedures, standards and regulations
- Provides guidance on compliance of software to procedures and standards including cyber security and privacy requirements
- Reviews and approves change orders for product performance, process changes, labeling and marketing communications as required.
- Other duties as assigned
