Christie Marr
Salem,Wisconsin
Summary
Knowledgeable, results-driven leader with proven background in senior leadership roles, driving strategic initiatives and fostering organizational growth. Successfully led cross-functional teams to achieve key business objectives, enhancing operational efficiency and stakeholder satisfaction. Demonstrated expertise in project management and strategic planning.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Senior Director of Quality and Regulatory
Vonco Products
08.2022 - Current
- Member of Executive Leadership Team providing input on strategic initiatives supporting quality, regulatory, and operations functions within the organization and advise on improvement opportunities in company processes
- Recommend and champion strategic initiatives and improvements in processes, tools, and cross departmental initiatives to optimize teams and efficiency of the organization
- Responsible for overseeing development and implementation of quality system processes throughout the organization
- Manage, develop, and direct Quality Managers
- Responsible for communicating expectations, monitoring of quality data, enforcing quality system processes and procedures, assessing plant performance utilizing key process indicators, quality integration planning to ensure planned projects and deliverables can be met with quality and on time
- Responsible for analyzing the quality system and developing quality and regulatory objectives and metrics
- Works closely with all functional areas to ensure thorough understanding of quality system and requirements
- Identifies methods, resources, and technologies to improve quality functions and company Quality/Regulatory requirements
- Plays a key role in presenting effective implementation strategies to Customers on complex projects
- Develop and document procedures and action plans to define new systems and continually improve existing systems and processes
Director of Quality & Regulatory
Vonco Products
04.2022 - 08.2022
- Direct activities of quality and regulatory functions
- Responsible for all third party and regulatory agency audits/inspections
- Supervised design control and risk management to ensure compliance with standards and regulations
- Responsible for maintaining the quality system and reporting on quality and regulatory objectives and metrics
- Coach, mentor, develop, direct, train and evaluate the work of quality improvement personnel
- Ensure customer satisfaction with product quality
- Creation and execution of IQ/OQ/PQ protocols and final reports, control plans, risk analysis documentation, and process flow diagrams
- Serve as ISO Management Representative
- Receive and provide communications and related materials/reports regarding part revisions, parts on hold, dimensional analysis, part rejections, part changes, qualifications, validations, internal audit data and other information required by the customer regarding quality
- Provide internal training in all aspects of the Quality Management System functions
Quality Manager
Vonco Products
03.2019 - 03.2022
- Maintain a robust Quality Management System that meets all ISO 13485
- Responsible for maintaining the effectiveness and suitability of all document control activities including; creation of procedures, revision history, document and record retrieval, document change control processes for quality procedures/part prints/work instructions/forms, ensuring proper distribution of production procedures, and issuing training as required for new/updated procedures
- Receive, interpret, and implement corrective actions as required by the customer relating to product quality
- Implement changes in the process and procedural requirements to improve product quality
- Oversee the internal audit and CAPA programs
- Support all customer audits, FDA inspections, and notified body audits, and provide all requested documentation
Quality Manager
Viant Medical
06.2017 - 03.2019
- Responsible for the implementation and maintenance of a comprehensive quality system that meets ISO 9001 and ISO 13485 requirements
- Manage the Quality Team to meet organizational goals and customer expectations
- Collaborate with cross-functional organizations to facilitate successful execution of lean initiatives, production plans and product development processes
- Oversee, coordinate, and support continuous improvement, control plans, quality plans and validations using statistical methods relevant to manufacturing processes
- Provide ongoing metrics, communications, and support to Plant Management toward attainment of objectives
- Perform and coordinate qualification activities in accordance with internal processes
- Responsible for management of quality team in a manner that fosters a self-directed and collaborative team approach
- Interview, hire, and establish training plans for direct reports
Supplier Quality - Customer Advocacy Analyst
Vyaire Medical
05.2014 - 06.2017
- Responsible for post-market surveillance, complaints, adverse events, field corrective action/recall management, domestic and international customer and agency notifications/communication, failure investigation/root cause problem solving, and risk management in compliance with regulatory agencies and standards
- Responsible for the completion of all tasks associated with management of complaint handling including, reviewing, investigating, resolving, replying and trend reporting in conjunction with failure investigation team
- Assess the severity of complaints and determine how to communicate the complaints for regulatory compliance and optimal root cause resolution
- Member of internal audit team assisting with ensuring facilities meet all requirements of the quality management system
Quality Engineer
Hollister Incorporated
04.2013 - 05.2014
- Manage ISO 13485 Quality System for Global Contract Manufacturing
- Perform audits of third-party manufacturing sites
- Investigate audit findings and close actions appropriately
- Provide input and documentation as needed during FDA inspections and additional regulatory agency inspections/audits
- Monitor and manage supplier quality for finished goods manufacturers
- Ensure contract manufacturing facilities meet requirements of the quality system, work processes and resources
- Develop strategy for documentation control efforts to harmonize quality system within Global Contract Manufacturing
- Work with contract manufacturers to investigate and report issues related to customer complaints
- Coordinate, review and approve product changes
- Coordinate process validation, process control and process capability studies to ensure that quality controls are maintained during the startup of new products
Senior Quality Technician/Associate Quality Engineer
Hollister Incorporated
06.2010 - 04.2013
- Review Design History records, approve sterilization and microbiology reports and release finished goods for shipment to distribution centers
- Complete monthly quality metrics for Global Contract Manufacturing
- Complete document changes as needed and route for approval
- Complete rejection documentation for contract manufacturers who have been approved for direct shipment
- Add input to CAPA’s and Nonconformance Concessions
Regulatory Affairs Coordinator
Hollister Incorporated
08.2007 - 06.2010
- Provide regulatory support for product registrations in various countries by gathering and submitting all required documents to the appropriate governmental agencies
- Responsible for the maintenance of EU documents, Canadian Medical Device Licenses, Australian Declarations and Certificates to Foreign Government
- Collaborated with internal teams to ensure that regulatory requirements were met for the submission and approval of new medical devices to various markets as well as providing input for regulatory requirements needed due to product changes
Education
Executive Leadership Certificate -
Cornell University
09.2021
Bachelor of Science -
University of Phoenix
06.2009
Adrian College
04.1998
Skills
- Quality Management
- Quality & Regulatory Compliance
- 510K Submissions
- ISO 13485
- IQ/OQ/PQ
- Strategic Planning
- Problem Solving
- Data Analysis
- Talent Development
- Communication
- Collaborative Leadership
- Team Management
Certification
- ASQ Certified Manager of Quality/Organizational Excellence
- ASQ Certified Quality Engineer
- ASQ Certified Quality Auditor
Accomplishments
Successful submission and approval of 510k for Closed System Enteral Feeding Product including completion of Human Factors Validation for Over-the Counter usage.
Facilitated Kaizen events to improve quality processes across customers to drive improved product quality and cost savings.
Timeline
Senior Director of Quality and Regulatory
Vonco Products
08.2022 - Current
Director of Quality & Regulatory
Vonco Products
04.2022 - 08.2022
Quality Manager
Vonco Products
03.2019 - 03.2022
Quality Manager
Viant Medical
06.2017 - 03.2019
Supplier Quality - Customer Advocacy Analyst
Vyaire Medical
05.2014 - 06.2017
Quality Engineer
Hollister Incorporated
04.2013 - 05.2014
Senior Quality Technician/Associate Quality Engineer
Hollister Incorporated
06.2010 - 04.2013
Regulatory Affairs Coordinator
Hollister Incorporated
08.2007 - 06.2010
Bachelor of Science -
University of Phoenix
Adrian College
Executive Leadership Certificate -
Cornell University
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