Roles and Responsibilities

• Assists in ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility

• Leads, acknowledges, develops, communicates & implements a strategy to ensure compliance

• Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site

• Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, Lean Manufacturing, 5S, SPC, engineering studies, DOE, Gauge R&R, etc.

• Leads process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans, including Master Validation Plans (Site Level), Validation Master Plans (Product or Process specific plans), and the development of detailed process flow diagrams that describe critical process interdependencies with respect to process inputs, outputs, risks and impacts

• Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops, and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program)

• Utilizes risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc. Supports design mitigation efforts. Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process

• Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation

• Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager

Required Qualifications

• Bachelor's Degree or a minimum of 7 years work experience

• Minimum of 3 years’ experience in a regulated industry

• Ability to communicate effectively in English (both written and oral)

• Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications

Desired Characteristics

• Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485

• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes

• Demonstrated knowledge of Quality Management System related to calibration and calibrated assets

• Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.

• Demonstrated collaboration, negotiation & conflict resolution skills

• Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance

• Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment