Detail-oriented and motivated professional with ** years of experience in FDA regulated medical device industry; including over 10 years of employee management. Seeking to take the next career step within an organization dedicated to world class quality. Skilled in working with cross-functional teams and multiple levels within an organization, demonstrating exceptional communication skills, and making critical decisions during challenges. Ability to manage multiple responsibilities with urgency utilizing strong project management skills.

Proficiency in collecting and analyzing data to identify root cause and ensure verification of effectiveness plans are comprehensive, to facilitate overall improvement in performance of key quality system elements appropriately and efficiently. Competency in monitoring metrics for determining the effectiveness of quality systems, developing processes and quality plans to address improvements and compliance as identified through remediation, audits and CAPA process.

Technology experience in PLEX, MoreStream, uniPoint, SysPro, EtQ, CMS, Enovia, JD Edwards, Plotview, XA, WOW, Rally, SharePoint, LiveLink and Microsoft Office Suite, including Excel, VISIO and PowerPoint.

Knowledge of FDA Regulations and Medical Device Quality Systems relating to 21 CFR Part 11; 21 CFR Part 210 & 211 (cGMP); 21 CFR Part 820 (QSR); ISO 13485:2016 Quality Management System Standard and ISO 14971:2019 Risk Management Standard.

Areas of Expertise:

ISO, FDA Regulations, Compliance Audits, Validation & Verification, IQ/PQ/OQ, Software Validation, cGMP, SOP, CAPA, FMEA, PPAP, SPC, MSA & DOE, Medical Device (Class I, II, II) Manufacturing

EDUCATION

Grace College

Winona Lake, IN

Major: Quality Management, BS

Relevant Coursework: Quality Systems, Post-Market Surveillance, Manufacturing Quality and Supply Chain Management,

Design Control and Assurance, and Statistical Processes

Project Management Certificate: IPFW October 2014

Yellow Belt Certification: Zimmer, Inc June 2012

PROFESSIONAL EXPERIENCE

Ventec Life Systems

Quality Systems and Compliance Manager August 2020-Anticipated end date December 18, 2020 (due to Kokomo plant closing)

Responsible for assuring processes are executed in compliance with company policies and procedures, as well as the FDA Quality System Regulations and International Regulations including 21 CFR Part 820, ISO 13485:2016 and E-MDR-2017/745 Standards.

Supported company during successful completion of 30,000 ventilators commissioned by the government in partnership with General Motors (GM) in anticipation of the continued Covid19-corona virus pandemic.

Developed and delivered corporate-wide “Introduction to Quality Requirements” training to support remediation activities.

Identified and recommended to senior management areas for improvement to existing processes and procedures, as well as identifying the need for the development of new processes and procedures to eliminate improve efficiency and eliminate non-conformity issues.

Process owner/Subject Matter Expert (SME) for updating/creating procedures for Internal Audits, Health Hazard Evaluation (HHE), Field Actions Reporting, Corrective and Preventive Action (CAPA) and Design Transfer.

Worked with management team in developing long and short-term business goals and strategies to drive process improvement across the organization.

Participated in the preparation and execution of corporate Management Review; and supported the preparation of regulatory inspections and internal audits

Coordinated and participated in test script validation with development team to support new release of Salesforce software.

Advised internal business partners regarding medical device standards and regulations.

Direct reports are Document Control Specialists which included ECO, MRB, Quality Alerts, and Training responsibilities.

Supporting decommission activities for the manufacturing facility in Kokomo, IN; moved to Bothell, WA

Creative Foam, Healthcare Division

Quality Systems Manager February 2019-July 2020

Responsible for the optimization of the Quality Management System to ensure compliance with cGMP (Good Manufacturing Practices); and assure adherence to ISO 13485, ISO 14971, and FDA regulations.

Served as primary Management Representative during internal, ISO/FDA and Customer/Supplier audits; and accountable for reporting audit observations and timely completion of associated corrective/preventative actions.

Responsible for FDA annual device establishment registration: and maintaining ISO 13485 certification

Established standards and criteria to ensure audit readiness by conducting internal audits of quality systems, processes, and products to ensure compliance with regulations and internal specifications; and oversee corrective action process subsequent to substandard audit results, which may include process analysis and modification, remedial education and possible initiation of disciplinary actions.

Continually reviewed operational data and processes to identify improvement opportunities; and worked with Operations and Engineering to perform root cause analysis to develop implementation plans to improve performance.

Motivated company personnel to focus on Total Quality by conducting training of quality initiatives and FDA awareness training; and actively support the Company policies, procedures, and workplace rules including environmental, health, and safety objectives to ensure compliance to keep our people safe and minimize risk.

Utilized quality system performance KPIs to drive performance improvements; and report results to senior management team.

Managed document control, CAPA/SCAR system, non-conformance (NCR), customer complaints, and problem reporting.

Responsible for the monitoring and analysis of scrap and rework costs; served as a primary member of the Material Review Board (MRB).

Reviewed and approved project plans, requirements/specifications, APQP, SPC, IQ/OQ/PQ validation and verification plans and master validation plans, and risk documentation (pFMEA) and quality/regulatory product standards assessments.

Developed a strong quality team to improve customer satisfaction and quality objectives; and acted as the quality interface for customers, implementing customer specific quality requirements and assuring conformance.

Managed the day-to-day operations of the Quality team consisting of Quality Technicians/Inspectors and Quality Engineer.

Zimmer Biomet, Inc. August 2013-February 2019 Quality Assurance, Regulatory Compliance Associate (Z12)

Lead CAPA owner to remediate pre-merger PPAP documentation issues from the Investigation Phase through the VoE Phase utilizing EtQ system; analyzed and defined the root cause by Brainstorming and Process Mapping; and used 5 Whys to compile the information to address the items collected from the Investigation plan; assured compliance with 21 CFR 820.100.

Partnered with CAPA Leads in gathering research data, including performing complaint searches and gatekeeper requests.

Supported management during audit inspections as required and assisted with supporting with FDA (or Notified Body) inspections on regulatory requirements and quality processes compliance specific needs such as external audit preparation, assessment of quality plans, responses to internal and external audit observations.

Facilitated cross-functional teams in activities required to launch global regulatory affairs impact assessment and global manufacturing/production transfer validation documentation; including assigning project tracking number in SharePoint, identifying appropriate approvers, and verifying product scope and project description are accurate and complete.

Ensured all manufacturing transfers comply with 21 CFR 820 and ISO 13485 standards and internal SOPs; including PPAP/SPPA and Good Documentation Practices (GDP) requirements are completed prior to final manufacturing transfer release by performing post execution QA compliance audit as the final post execution approver.

Collaborated with Senior Management and Manufacturing Engineers in prioritizing manufacturing transfer activities to meet production deadlines to avoid backorders and supplier issues.

Conducted Senior VP and Director level management meetings to review status of current manufacturing transfer projects; and present tracking and trending data with analysis on how to improve trends.

Participated in Kaizen activities to enhance the transfer process and documentation archiving procedures.

Supported global label team with compliance activities for FDA GUDID requirement.

Assisted Supplier Quality Engineers with processing supplier change notifications and supplier desktop assessments.

Zimmer, Inc. May 2012-August 2013

Document Control Procedure Coordinator

Initiated, reviewed, and approved policies, procedures, and work instructions in CMS.

Supported FDA and BSI audits and inspections as scribe and runner.

Archived risk management, DHF, PFMEA/DFMEA, and manufacturing transfer files.

Zimmer, Inc January 2010-May 2012

Customer Financial Services Representative

Maintained documentation of all collection activities, and credit files for each account.

Worked closely with distributors to resolve invoice disputes and discrepancies.

Analyzed credit worthiness of accounts by investigating information provided on credit application, and D&B, Experian, and trade reports to recommend credit terms and condition to management for approval.

Consistently meet cash quota of $16 to $18 million per month; $200 million annually. Kept 85% of accounts within 30 days net terms with DSO average of 35 days.

Generated monthly significant event management reports.

Neopost, Inc. November 2002-October 2009

Dealer Relations Manager

Managed 100+ Neopost dealer accounts.

Collaborated with Sales Representatives to resolve order and pricing issues.

Achieved 50% reduction in over 60 days accounts receivable balance within 6-month time.

Met with dealers to negotiate payment plans and make arrangement for equipment returns.

Facilitated discussion panel with dealer administrative staff to proactively identify billing or system issues and reported findings with proposed solutions to management.

Provided financial reports for senior management.

Prepared documentation for Corporate Counsel when legal action was necessary to recover receivables.

Entered monthly commission payments on dealer accounts.

Neopost Online, Inc. November 2000-November 2002

General Manager, Field Network Operations

Managed staff of 35+ in Customer Relations, Logistics, Shipping and Receiving, and Administrative departments.

Directed technology rollout in 250 supermarket locations in three major markets – Arizona, Colorado, and Texas: including communicating with corporate clients concerning installation and training schedules.

Participated in strategic planning with executive team concerning installation projections.

Negotiated pricing with suppliers resulting in 30% price reduction for in-store forms.

PackageNet, Inc. November 1996-November 2000

Client Relations Manager

Managed staff of 10 in Client Relations department; including supported 3 Sales Representatives in Texas and Arizona.

Introduced new marketing initiatives and provided service education for clients.

Documented and maintained reports related to discussions and feedback provided by customer and presented reports to appropriate department to enable further improvement in products/services.

Assisted the department involved and top-level management in solving severe issues which may have been produced due to company’s services or products.

Prepared product and marketing presentations for VP of Sales.

Exceeded targeted results in customer retention, client expectations, sales, and support service as well as other customer service goals.

Developed manuals and procedures for department.

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