Quality System Auditor, Supply Chain Manager - Medical Health Resume S
Quality System Auditor, Supply Chain Manager - Medical Health Resume S
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Quality System Auditor, Supply Chain Manager Resume


Desired Industry: Medical/Health SpiderID: 80840
Desired Job Location: Lakeville, Pennsylvania Date Posted: 4/6/2018
Type of Position: Full-Time Permanent Availability Date:
Desired Wage: 75000
U.S. Work Authorization: Yes
Job Level: Management (Manager, Director) Willing to Travel: Yes, 50-75%
Highest Degree Attained: Masters Willing to Relocate: Yes


Experience:
MTF Biologics, Jessup, PA
Associate Project Manager • 2016–Present
Quality Assurance and Auditing
Keenly review product documentation to ensure compliance with internal procedures and statutory requirements
Collaborate with Regulatory Affairs and Quality Assurance to guarantee compliance of assigned projects with current good manufacturing practice (cGMP), quality system regulation (QSR), good tissue practice (GTP), Food and Drug Administration (FDA), and American Association of Tissue Banks (AATB) standards

Project Management
Lead the conceptualization, development, management, implementation, reporting, and maintenance of project plans
Supervised project team meetings to communicate routine project updates and meeting minutes
Establish timelines, milestones, risk mitigation strategies, and goals for assigned projects
Contribute to the implementation of corporate-wide systems, procedures, and structures that provide efficient project management

Supply Chain Management
Take charge of sourcing, procuring, managing, and maintaining inventory for various raw materials, ensuring consistent and improved quality while achieving significant cost savings across the foundation
Manage, maintain, and monitor all supply chain facets of MTF production lines, including Cascade Autologous Platelet System, Lipografter, and Mesobiomatrix
Act as the department representative on several teams, tasked with the following corporate goals and initiatives:
*Multiple product line launches
*Supplier assessments, risk assessments, and qualifications
*Conducted Investigations, root cause analysis, disposition, and closure with Nonconformance Teams
*Served as the Supply Chain corrective and preventive action (CAPA) and Nonconformance (NCR) Coordinator

Associate Manager, Contracts and Value Analysis • 2012–2016
Quality Assurance and Auditing
Participated in inventory valuation and reductions to maintain cost-effective levels while achieving optimum production levels
Supervised the activities of the Strategic Supplier Monitoring Program to ensure supplier and quality compliance, which included conducting supplier risk assessments

Supply Chain Management
Directed several teams and departments, including supply chain specialists, Central Supply Packaging, and Material handling and Receiving
Provided leadership to contract management and material management to guarantee outstanding support and service for operations in accordance with AATB, FDA, and ISO standards and regulations
Managed supply chain cost saving initiatives related to labor, distribution, and use of raw materials
Handled the negotiation of strategic supply and quality agreements as required, including nondisclosure, joint development, intellectual property, and other agreements to ensure positive relationships with a base of critical and key supplier partners

Supply Chain Management Specialist • 2011–2012
Quality Assurance and Auditing
Served as part of the Supplier Quality Management Team in providing supplier performance analysis
Collaborated with business unit leaders during the budgetary process through material data collection, as well as tracking and trending budget items in real time to better position the business unit’s needs and cost allocations

Supply Chain Management
Contributed to the negotiation, oversight, and management of supplier contracts and agreements to ascertain legal and financial compliance, and implemented performance criteria based on customer and supplier requirements
Partnered with Research and Development, Process and Quality Engineering, and Operations on projects that connected to new tissue commercialization requiring material, chemical needs, or solutions
Rendered support to value analysis programs to determine opportunities for cost efficiencies related to product, service, and process standardization and utilization
Functioned as part of the Material Review Board, which entailed reviewing potential new raw materials for quality and supply chain requirements to ensure compliance with internal and external procedures and regulations

Quality Assurance Auditor • 2007–2011
Quality Assurance and Auditing
Organized, initiated, reported, and followed up on audits on internal operations, suppliers, and external organizations to guarantee procedural, contractual, standard, and regulatory compliance
Generated reports on audits, trend analysis, non-conformances, and complaints to management to support decision-making processes
Function as the foundation’s representative on all regulatory audits performed by regulatory bodies, including FDA, ISO, international regulatory bodies, business partners, and state regulatory units

Administrative Functions
-Acted as the CAPA coordinator in managing adverse event reporting, CAPA actions, and recalls, which included database and file controls, investigation, reporting, regulatory notification, customer interface, corrective action, and follow up
-Facilitated training on quality assurance and regulatory affair topics

Earlier Positions Held:

Central Supply Technician • 2005–2007
Quality Assurance Technician • 2000–2005


Education:
Master of Business Administration
Wilkes University, Wilkes Barre, PA

Bachelor of Business Administration
Wilkes University, Wilkes Barre, PA

Associate of Science in Business Administration
Lackawanna Junior College, Scranton, PA

Strategic Procurement & Supply Management (SPSM) Certification
ISO 9001 Certified Auditor/Lead Auditor


Skills:
Technical Skills

Microsoft Office (Excel, PowerPoint, Project, and Visio) • Internal SAP system (QAD)
Internal Document Control System (Master Control) • SharePoint Application


Additional Information:
Qualifications Profile

Goal-driven and detail-oriented professional with extensive experience in quality assurance, quality system and supplier auditing, and supply chain management in the medical device industry. Effective in identifying, analyzing, and mitigating risks; analyzing contracts and value; and performing both internal and external audits. Equipped with articulate communication and interpersonal skills in building positive work relationships with clients and professionals of all levels.

Professional Development

Part 11 Training, EduQuest
CTBS Examination Review Course
Strategic Procurement & Supply Management (SPSM) Certification
ISO 9001 Certified Auditor/Lead Auditor


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