Serena Case, Ms, Alb, Acg Email & Phone Number

Warsaw, In, Us

Bremen, In, Us

Develop and implement ISO 13458:2016 quality standards.Develop and implement quality control systems.Monitor and analyze quality performance throughout multiple facilities.Manage internal audits as Lead AuditorInspect and test materials, equipment, processes, and products to ensure quality specifications are met.Collaborate with operations managers to develop and implement controls and improvements.Ensure that workflows, processes, and products comply with safety regulations.Investigate and troubleshoot product or production issues.Develop corrective actions, solutions, and improvements.Review codes, specifications, and processes.Provide training and education to facility employees regarding the Quality Management System.Support verification and validation efforts

Some of the essential functions of my role were:•Vendor and company ERP software implementation consultant and liaison to ensure software compliance to cGMP, ISO 13485:2016, 21 CFR Part 820, 21 CFR 803, 21 CFR 806, and 21 CFR Part 7 Subpart C.•Responsible for writing, developing, reviewing and monitoring procedures, work instructions, and forms to be compliant and in alignment to new ERP software and QMS.•Managed complaint handling and CAPAs, determining root cause and conduct investigations through E2 MFG software system, documenting within the system to “tell the story” of the investigation and implement corrective actions that are determined, through follow-up, to prevent recurrences.•Leading internal and external supplier audits to monitor supplier’s quality management system and specific processes for products per the annual audit schedule or as indicated by performance monitoring triggers.•Developing risk management controls and providing objective review of risk management and verification and validation activities.•Support facility, process and equipment qualifications and validations, including writing and approving protocols and reports.

Bremen, In, Us

• Developed, maintained, and controlled inspection criteria and control plans in compliance with Good Document Practice (GDP), Good Manufacturing Process (GMP) and Standard Operation Procedure (SOP).• Developed procedures for identification and calibration/verification of inspection equipment.• Developed, maintained and implemented procedures for corrective and preventative actions.• Lead, conducted and documented internal audits to ensure CFMS met the regulatory requirements of ISO 9001 and ISO:13485:2016.• Responsible for developing, documenting, and training CFMS personnel. • Supported and contributed to Kaizen projects to ensure quick implementation of identified improvements. • Coordinated with Engineering, Purchasing and Production on troubleshooting issues related to inspections.• Developed calibration procedures and methods according to blueprints and technical requirements

Cincinnati, Oh, Us

•Conducted pre-study, initiation, monitoring, and close-out visits according to SOPs and GCP.•Responsible for overall site management for assigned sites including written and verbal communication and scheduling of monitoring visits.•Responsible for completion of visit reports and maintenance of study-related databases.

Raynham, Ma, Us

Shortly after starting the Medical Device Quality Management (MDQM) Masters program at Grace College, I was offered an amazing opportunity to work at DePuy providing support to the Continuous Improvement and Process Quality teams. I walked into the job with transferable skills from an educational foundation in health sciences and regulatory, as well as 15+ years in the manufacturing industry, but very little experience with database management or engineering. I am amazed at how much I have learned, accomplished and grown during my DePuy experience. This was one of the most challenging, yet rewarding careers I have ever experienced and I am grateful every day for the amazing opportunity to provide support to incredible people from manufacturing, maintenance, regulatory, quality, calibration and receiving inspection. Some of the skills that I obtained while at DePuy are:•Responsible for capturing front room audit events and processing requests for the back room during FDA, BSI and JJRC audits.•Developing manufacturing control plans and leading cross-functional teams on gap reviews, critical control point identification and approval routing. •Constructing validation protocols and reports for new or modified production equipment.•Applying continuous improvement methods to enhance manufacturing quality, reliability, and cost-effectiveness.•Generating and maintaining spreadsheets to track non-conformance data and communicate discrepancies to management.•Leading an FPX project team to identify critical issues, correct errors and clarify instructions to over 80 inspection criteria. •Proficiency in multiple software applications such as SAP, MS Office, ETQ nonconformance system, Adaptive PLMS and Maximo asset management. •Became FPX Project Management Certified•Expanded my knowledge of QSR and ISO regulations (CFR 21 Part 820, ISO 13485 & 14971)• Motivated co-workers with infectious smile. :)

I was the primary instructor for my child during grades eight through graduation. My duties included: •Selecting, developing and implementing appropriate curricula.•Teaching all subjects and evaluating student performance.•Maintaining student records, complying with all state laws and reporting procedures.•Administering standardized tests.•Choosing and providing extracurricular activities.•Overseeing lab experiments.•Providing discipline and guidance.

Us

• Responsible for ensuring the production of high quality racing tires for competitive racing professionals.• Ensured compliance with strict cGMP requirements through constant monitoring of safety and housekeeping activities.• Supported LEAN Manufacturing pilot.• Set up and safely operated diverse machinery.• Assisted nearby employees as needed to maintain optimal product flow.• Measured dimensions with various devices to ensure correct output.• Motivated co-workers with infectious smile. :)

Warsaw, Indiana, Us

• Examined and measured extruded material to verify conformance to standards using measuring devices such as micrometers and calipers. • Trained and mentored new associates.• Motivated co-workers with infectious smile. :)

Master'S Degree, Medical Device Quality Management

Master’S Degree, Orthopedic Regulatory And Clinical Affairs

Bachelor'S Degree, Business Administration And Management, General