The position is responsible to ensure that activities throughout the product lifecycle are in compliance 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, 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
- Interprets regulations and procedures to ensure documents are sound and defensible to auditors and regulatory bodies.
- On projects of significant scope, leads successful implementation of Design Control and Product Realization requirements for design, production and distribution of IL products
- Provides input on product requirements, acceptance criteria, traceability, process monitoring, product evaluation, failure investigation and complaint analysis.
- Ensures 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.
- Provides guidance on compliance of software to procedures and standards including cyber security and privacy requirements
Other
- Advises and directs teams regarding compliance to procedures, standards and regulations
- Participates on core teams supporting new product development or design changes.
- Defends relevant quality topics in audits and corrective actions to improve and maintain compliance of the QMS
- Works with manufacturing, R&D, Service, Distribution, Sales & Marketing, and others outside the company (as needed) to recommend or prepare corrective/ preventive actions (CAPA).
- Reviews and approves change orders for product performance, process changes, labeling and marketing communications as required.
