Renata Kennedy
Tucson,USA
Summary
Quality management professional with robust background in driving process improvements and ensuring compliance with industry standards. Strong focus on team collaboration and achieving results, consistently adapting to changing needs. Skilled in quality assurance, risk management, and operational efficiency. Known for reliability, leadership, and strategic vision.
Overview
15
15
years of professional experience
Work History
Director of Quality
SynCardia Systems
03.2024 - Current
- Responsible for all quality assurance and improvement initiatives to ensure regulatory compliance and operational excellence across company processes and products.
- Responsible for the creation and maintenance of quality policies, procedures and documentation that align with industry standards and regulatory requirements, and company goals.
- Quality management system oversight to include documentation, training, process monitoring and data analysis to ensure consistent quality across operations.
- Management Representative, responsible for leading external audits, overseeing internal audits and process monitoring to identify quality issues and nonconformities.
- Manage and develop a team of quality professionals including Quality Engineers, Quality Specialists, and Document Control.
Quality Assurance Manager
SynCardia Systems
08.2022 - 03.2024
- Mentored staff members in best practices for quality management, contributing to overall team growth and development.
- Audit Program management to ensure conformity to all applicable regulatory standards and process requirements.
- Implemented process improvements to meet compliance and corporate objectives related to Supplier Quality, Audit, Training, CAPA, and Complaint Handling.
- Implemented corrective action plans based on audit findings, resulting in measurable improvements over time.
- Performed root cause analysis to identify and resolve quality issues and defects.
- Trained team members on quality assurance principles, fostering a culture of accountability and high performance.
- Conducted risk assessments to identify and mitigate potential quality issues.
Senior Quality Engineer
SynCardia Systems
06.2021 - 08.2022
- Implemented internal audit process improvements to strengthen compliance requirements and resolve aging internal audit findings.
- Implemented a rejected material process and revised the expiring material process to drive a reduction in volume of nonconforming material reports (NCRs) related to scrap.
- Implemented changes to servicing procedures to comply with regulatory changes to complaint management.
- Reviewed and revised quality system procedures and documents to support company-wide integration to upgraded Quality Management System
- Completed risk assessments for CAPA, Nonconforming Product, and New Product Development.
Senior Quality Engineer/Process Engineer (Contractor)
Avanos Medical
07.2020 - 06.2021
- Led lean initiative to improve in-process inspections for digestive health product line that resulted in a 25% reduction in scrap
- Provided Quality Engineering oversight for respiratory health product manufacturing line for closed suction catheters
- Escalated and investigated nonconforming product issues including supplier quality issues
- Led QNC (NCMR) investigations, identified and implemented corrective action plans in collaboration with partners in Engineering and Operations
- Conducted quality system and product related training
Senior Quality Engineer
Westmed, Inc.
12.2019 - 07.2020
- Supported external inspections, performed root cause analysis and corrective action implementation to address regulatory audit findings
- CAPA process manager
- Internal Auditor
- Performed NCR investigations and material disposition through MRB
- Performed Customer Complaint Investigations
- Identified and implemented Quality System improvement initiatives to improve manufacturing personnel competency to regulatory requirements
- Reviewed and revised policies and procedures to maintain compliance to Regulatory requirements
Senior Regulatory Compliance Auditor
CBR Systems, Inc.
09.2018 - 12.2019
- Supplier Quality Management
- Supplier Audits and Supplier Monitoring
Quality Engineer
CBR Systems, Inc.
02.2018 - 09.2018
- Supplier Quality Management
- Nonconforming Product Investigation and Disposition
- Implemented Incoming Inspection defect standards to drive reductions in rejection and scrap
Sr. Quality Assurance Specialist
CBR Systems, Inc.
06.2017 - 02.2018
- Implemented process improvements for CAPA
- Collaborated with cross-functional management to execute Root Cause Analysis and implement Corrective Action to eliminate Audit nonconformances
- Led initiative to drive more than twenty aging CAPAs to closure in six months reducing the volume of open CAPAs by 25%
Quality Systems Manager
SynCardia Systems, LLC
01.2017 - 06.2017
- Led improvement project to overhaul the training system by redefining roles assigned in accordance with job function across the organization
- Enhanced the training program with additional Quality centric training to improve employee understanding of QMS requirements
Assoc. Quality Engineer
SynCardia Systems, LLC
12.2015 - 01.2017
- Led improvement project to implement changes to drive a reduction in cycle time to support timely complaint closure
- Managed failure investigations related to customer complaints
- Quality metric tracking and trending, complaints, investigations, NCRs, CAPA, Training and Audit
Senior Quality Specialist
SynCardia Systems, LLC
07.2015 - 12.2015
- Implemented internal audit process changes which resulted in 100% closure of all aged findings in 6 months
- Prepared the Internal Audit schedule
- Internal audit assignment and resource management
- Internal Audit nonconformance metric trending for Management Review
Quality Specialist
SynCardia Systems, LLC
07.2013 - 07.2015
- Improved CAPA closure rate by 200% in one year
- Implemented process changes to reduce CAPA cycle times and improve overall process timeliness
- Provided direct support to CAPA owners in root cause identification, corrective action plan creation and implementation
- Managed completion of effectiveness monitoring and verification activities as needed
- Reviewed and revised CAPA Procedures and documentation
- CAPA metric trending for Management Review
Marketing Coordinator
SynCardia Systems, LLC
05.2010 - 07.2013
- Managed CRM database to maximize customer outreach efforts and strengthen client relationships.
- Implemented customer feedback mechanisms to gather insights, driving product improvements.
- Composed daily posts for social media and helped build corporate presence on Twitter, Facebook, and Instagram.
Education
Bachelor of Arts - Music Performance
Texas Tech University
Lubbock, TXSkills
- Root Cause Analysis Training, Quality One, June 2022
- ISO 13485:2016 Lead Auditor Training, BSI Group, March 2022
- ISO 14971:2019 Risk Management Training, NSF ProSystem GmbH, March 2022
- RAPS Training, Medical Devices, 2019
- Medical Device Supplier Quality Management Training, Oriel Stat a Matrix, August 2018
Professional Development: Training & Certification
- Certified Quality Auditor, American Society for Quality (ASQ), February 2017
- Design Control Training, EduQuest, Inc, August 2015
- Quality risk assessment
- Quality assurance techniques
- Corrective and preventive actions
- Operational excellence
Timeline
Director of Quality
SynCardia Systems
03.2024 - Current
Quality Assurance Manager
SynCardia Systems
08.2022 - 03.2024
Senior Quality Engineer
SynCardia Systems
06.2021 - 08.2022
Senior Quality Engineer/Process Engineer (Contractor)
Avanos Medical
07.2020 - 06.2021
Senior Quality Engineer
Westmed, Inc.
12.2019 - 07.2020
Senior Regulatory Compliance Auditor
CBR Systems, Inc.
09.2018 - 12.2019
Quality Engineer
CBR Systems, Inc.
02.2018 - 09.2018
Sr. Quality Assurance Specialist
CBR Systems, Inc.
06.2017 - 02.2018
Quality Systems Manager
SynCardia Systems, LLC
01.2017 - 06.2017
Assoc. Quality Engineer
SynCardia Systems, LLC
12.2015 - 01.2017
Senior Quality Specialist
SynCardia Systems, LLC
07.2015 - 12.2015
Quality Specialist
SynCardia Systems, LLC
07.2013 - 07.2015
Marketing Coordinator
SynCardia Systems, LLC
05.2010 - 07.2013
Bachelor of Arts - Music Performance
Texas Tech University
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