LINDSAY ANEST

I was hired to create and implement a Quality Management System in an Injection Molding company that was in a fragile state and needed a cultural overhaul

• Implemented Device History Record (DHR) Review prior to shipment release
• Closed out 4 major CAPAs from Customer Audits within the first 3 months
• Established confidence with strategic customers with regards to the Quality system and commitment to becoming the supplier of choice.
• Implemented a streamlined Change Control process, reducing 3 different process to one
• Initiated a culture of Quality by demonstrating how all pieces of the organization from PO to Cash are critical to customer satisfaction, QMS compliance, and overall business health
• Developed and Implemented a streamlined QMS network drive, replacing a haphazard and disjointed network storage
• Establish partnership between Engineering and Quality to better serve external and internal customers
• Developed and Implemented a streamlined Feedback Management System providing a risk based approach for evaluating all feedback and classification within a single process, replacing a process that involved three different processes and subjective classification
• Establish a robust Validation program
• Implemented an ISO 13485 appropriate Calibration program by setting guidelines and bringing in appropriate SMEs within Quality Engineering.
• Mentored and encouraged employees to strive for excellence while fostering professional growth.
• Improved quality processes for increased efficiency and effectiveness.
• Wrote and implemented new rework procedures to standardize processes and streamline workflow.
• Maintained positive customer relations by addressing problems head-on and implementing successful corrective actions.
• Maintained professional demeanor by staying calm when addressing unhappy or angry customers.
• Evaluated employee performance and conveyed constructive feedback to improve skills.
• Used industry expertise, customer service skills and analytical nature to resolve customer concerns and promote loyalty.
• Cultivated positive rapport with fellow employees to boost company morale and promote employee retention.

• I was accountable for day-to-day Quality Assurance and Quality Control activities related to the QMS and within the facility from Supplier Management, Receiving Inspection, Product Realization, and Outgoing quality activities. It is easier to ensure compliance to customer, QMS and regulatory requirements if all departments work together in every product related process.
• Manage a team of 4 Quality Engineers, Document Control, and 10 Quality Control personnel.
• Monitor and report Quality KPIs monthly to the Leadership Team.
• Host FDA, ISO, and Customer Audits.
• Support LEAN Manufacturing PFM and Kaizen Events to ensure the Business is always improving.
• Manage customer feedback
• Mentor staff within the Quality , Engineering and Operations departments.
• Integrated the Quality Engineers into the daily support of Product Realization starting with ownership of Non-Conformance Management.
• Drive cross functional activities to ensure a consistent culture of Quality by openly communicating Quality KPIs monthly across the BU.
• Reported Quality KPIs to Site General Manager.

• Manage 10 Quality Control personnel: Quality Technicians and Inspectors
• Maintained daily task schedules and align with shipping schedules to ensure OTIF is met
• The company doubled in revenue within a 4-year period which naturally led to an increase in the number of shipments
• Engaged with the most challenging customers to ensure their needs were met while staying true to validated processes
• Managed performance of the QC Team
• Managed all Customer Feedback, Internal Non-Conformances, and Resolutions
• Developed and implemented a brand-new production line and process, with new technology to the company, within 2 months to support a Covid related project with 100 temporary employees across 3 shifts
• Streamlined the Attribute Inspection criteria and improved verbiage used within work instructions to reduce variance in interpretation by operators
• Strategically assessed the QC Team to determine the optimal skillset and performance standards for the Technician group
• Developed and Implemented DHR review with the QC Group
• Created and implemented a new paper based DHR process due to the implementation of a new ERP system that did not have the traceability capabilities required to meet QMS requirements
• Co-Hosted Customer and ISO Audits
• Created and Managed the Training program
• Expanded the In-process verification process to the extrusion line once they exited validation.

• Added the additional responsibilities of supervising the Quality Attribute Inspectors
• Exposed and trained the Quality Attribute Inspectors to use email and basic excel
• Implemented in-process verification of molding equipment settings.
• Located and resolved problems with team production and performance to maintain consistent quality levels.

• Performed gap analysis of the current Quality Management System against ISO and FDA Regulations
• Performed internal audits
• Support third party and customer audits
• Became the attribute SME for the company's largest manufacturing transfer with the largest customer, including 130+ part numbers
• Evaluated the current training system and performed a reconciliation activity of all active employees and re-trained everyone
• Responsible for executing all onboarding training and developed an improved approach to onboarding molding operators to allow a more accurate job-fit assessment
• At this point in time the company was hiring 30 people per week.

• Developed, refined, and implemented practices and procedures with the manufacturing and production department, accommodating rapid business growth; renewal of annual licenses, registrations, and patent information
• Drove and managed the implementation of UDI regulations for Class II medical devices
• Conducted risk-benefit analysis for regulatory compliance on medical devices and PPE per ISO 14971:2012 and ISO 9001:2015
• Compiled, prepared, reviewed, and submitted regulatory submissions to authorities (FDA and other foreign regulatory authorities) 510(k) submissions, technical files, etc
• Collaborated with Engineering to develop documentation, drawings, engineering change notices; coordinates, prepares, submits, and monitors devices for regulatory testing
• Actively participated in ISO and FDA audits
• Fielded customers' regulatory related inquiries with rapid turnaround