Manage Thermoforming projects from receipt of customer purchase order through customer approvals

Quality Assurance Engineering Manager – (Facility ELT Member)• Managed QA staff including QA Supervisor, Receiving, In-process and Final Inspectors, QA Technicians, QA Resin Analyst, Calibration Specialist, Quality Engineers, and Data Analyst to support Molding and Assembly operations.• Implemented cross-functional MRB process to improve processing and reduce recurrence of nonconformances.• Processed customer complaints, customer and vendor returns, CAPAs and SCARs in Agile and Oracle.• Assist QA Management Representative in Customer and Registrar Assessments and Audits.• Report metrics internally and to Corporate (i.e., OTD, DPPM, RMAs, NCMRs, Customer Satisfaction, etc.)• Update and DCO QA Documents and review and approve Company documents in Agile.• Participates in the reviewing of engineering designs to contribute quality requirements and considerations.• Assists product support areas in gathering, analyzing, and reporting internal and corporate reporting.

I-Tek - ISO13485/FDA Registered medical device, design, development, manufacturing company in St. Paul, Mn from simple to complex device assembly, Sterile Barrier Packaging, Sterilization Management, Molding, and Machining.I-Tek Medical – QA Manager / ISO13485 QMS Representative Sep 2018 to Present• ELT Member, ISO QMS Representative. Complaint, RMA, CAPA, SCAR, and NC process coordinator.• Responsible for QMS Review, calibration, pest control, environmental monitoring, internal audits, preventative maintenance compliance, customer/supplier/internal audits, and online Learning Management System (LMS).• Collaborate with customers, suppliers, staff, and others to identify interim and permanent product solutions.• Review/Approve IQ, OQ, PQ, and Validation Protocols/Reports, Document Change Orders, Deviations, , First Article Inspections, Capability Studies, etc.

Plastech - ISO9000 custom injection molder and value-added assembler to a wide range of industries.Quality Assurance Manager / ISO9001 QMS Representative Aug 2014 to Aug 2018• Executive Leadership Team Member, QMS Management Representative, and primary QE support.• Implement common sense methods to reduce Scrap, PPM, COR, NCR reversing severe negative trends.• Optimize quality/engineering tools including DCO, APQP, PPAP, DOEs, MSAs, , and First Article Inspections, Capability Studies and other best practices.• Implement various reporting tools to identify top scrap contributor by products and categories.• Re-establish/implement effective methodologies (Pareto, 5 Why/Fishbone) to reduce & eliminate issues.

Taurus - Injection molder of Medical Device, Automotive, Entertainment, Consumer components.Quality Assurance Manager/ISO9001/ISO13485 Management Representative/Project Manager/IT Manager• Responsible for all aspects of quality assurance including working directly with customers, vendors, training production and quality personnel, implementing cost tracking/cost-reduction programs. Implemented process changes for preparation and attainment of dual ISO9000 / ISO13485 Certification.• Responsible for Process Validations (IQ, OQ, PQ), First Article Inspections, Capability Studies, Contract Review, PPAP, FMEA, CAPA, ECO, Calibration, Data Collection, Inspection Plans, Operator Instructions, Control Plans, Supplier Quality, Device Assembly Program, Inventory Control, System, and IT.• Support or perform most aspects of new business and transfer business program/project management.

Role: Specialized in coordinating Food Source Staff, Inventory Management, and IT for 501 (c) (3) non-profit food bank, increasing and stabilizing volume and variety of product, implementing inventory and technology processes, and fulfillment systems. Significantly improved employee morale and supply chain process.

Specialized in helping companies improve employee morale, reduce accidents, reduce absenteeism and tardiness, retain existing clients, gain new clients through referrals, and with behavior and incentive programs.

I-Tek is an ISO13485/FDA compliant medical device design, development and manufacturing company in St. Paul, Mn. In mid-2009 I-Tek purchased the contract manufacturing unit from Enova Medical Technologies.AM-BioMed - Independent Sales Representative for I-Tek Medical Technologies Jul 2008 to Mar 2010• Specialize in sale of blood and sera products and identifying products that can expand product offering.• Establish pricing, develop sales strategies, create call lists, perform cold-calls and sell products to research and diagnostic laboratories of Government, schools, colleges and commercial scientific centers.• Develop and implement strategies with vendors to improve growth, profitability, and customer satisfaction. Enova Mfg (now I-Tek) - Manufacturing Manager, then Sales Account Manager Dec 2006 to Jun 2008Hired for sales, and asked to temporarily change roles to rebuild failing contract manufacturing business unit.• Successfully reversed failing contract manufacturing unit during first months and returned to Sales role.• Managed Quality, Engineering, Production, Purchasing, Information Technology, and Sales.• As the Account Manager, expertly performed all aspects and phases of sales process.• Sought new business with those requiring assembly needing custom injection molding, EDM, machining, Swiss-screw machining, UV bonding, laser-welding, silicon molding, RF Welding, electro-mechanical, device packaging, sterilization or other operations in a Class 100 (Aseptic) or Class 10,000 Clean Room.

Sr. Sales Account Manager - Apr 2003 to Nov 2006• Managed and grew $18 million multi-site strategic account in U.S. and Puerto Rico from three facilities in Minnesota and one in Puerto Rico. Also developed and grew several new customer accounts.• Achieved highest quote/new business win rate, including “multi-million dollar, entire business” bids.• Significantly improved R&D quick-turn process increasing lead times, profits and new business pipeline.• Lead sales team and cross-functional teams on customer products and projects from cradle to grave.• Consistently pursued and implemented win/win process, product profit improvement opportunities.• Justified several new process investments, developed accurate sales forecasts and optimized pricing.• Served as product and project manager for most customer opportunities.• Lead transfer of critical products and processes from Minnesota to Puerto Rico as preferred partner.• Regularly organized and hosted events for customer and worked company booth at trade shows.Quality Manager - Oct 1999 to Mar 2003• Served as Management Quality System Representative.• Served as a primary interface with all customers and suppliers.• Managed several reports ranging from quality technicians and to quality engineers at several sites.• Lead complex disposition/reimbursement projects, recovering hundreds of thousands in costs annually.• Performed annual 5 year strategic planning and budgeting as part of senior management team.• Was an integral part of aggressive revenue growth from $5 million to $30+ million in approximately 4 years.• Improved several systems including DCO/ECO, RFC, RMA, NCR, CPAR, qualification and calibration.• Managed product transfers including bio-burden, cytotox and other testing requirements for customer.• Co-managed and implemented several formal and informal lean manufacturing initiatives.• Consistently tracked and implemented measures to reduce production scrap and COR.

ISO9000 & QS9000 ¬Quality System Coordinator, Calibration, CPAR Coordinator Oct 1994 to Oct 1999• Managed and improved quality audit, calibration, CPAR systems and lead continuous improvement plans.• Wrote multi-facility software for Inspection and Operation Control Plans, managing thousands of products.• Implemented Calibration tracking system with EOM capability and programmed CMM for SPC.• Implemented attribute data collection to track, report and trouble-shot production and assembly scrap. • Actively reduced ISO audit non-conformance/observations to very low single digits by improving system. • Used various tools including APQP, FMEA, PPAP, QSA, SPC, and MSA.