Position Summary
The position is responsible to ensure that activities throughout the product lifecycle are compliant with procedures, standards, and regulations applicable to our products. 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.

This is a technically focused role requiring advanced skills in analyzing information, reviewing technical reports, promoting process improvement, requirements development, risk management, product development and production controls

Key Accountabilities
Essential Functions:

• Participates in the generation and review of quality documents throughout the product lifecycle
• Advises and directs teams , in coordination with management, regarding compliance to procedures, standards and regulations
• 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.
• 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

Secondary Functions:

• Identifies compliance gaps and takes appropriate corrective actions as needed
• Supports internal and external audits
• Participates in quality system improvement projects as required.

Internal Networking/Key relationships

To be determined based on department needs, to include interactions such as:

• Works closely with other functions to generate compliant documents by interpreting and explaining quality procedures, applicable standards, regulations and best practices.
• Able to effectively communicate quality requirements to a broad population of constituents.
• Ability to negotiate and influence others in establishing direction toward improved quality and enhanced compliance.

Skills & Capabilities:

The incumbent in this position will exhibit the following skills and capabilities:

• 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.
• Recognition of when to escalate issues to management or consult with more senior staff members.

Minimum Knowledge & Experience required for the position:

• Education: Bachelor's degree or equivalent in engineering or science
• Experience: A minimum of 5 years of experience in medical devices, pharmaceuticals, diagnostic industry, or clinical laboratory or 2 years of experience with an advanced degree

Additional Skills/Knowledge:

• 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.
• ASQ Quality Engineering Certification - Desirable
• LEAN/Six Sigma Certification - Desirable
• Language: English

Travel requirements:

• Approximately 10% of time