Alben Mokrzycki Email & Phone Number

Belmont, NC, US

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

San Jose, California, US

• 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.
• 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.)

White Bear Lake, Minnesota, US

• 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.
• 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.

Rush City, MN, US

• 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.

Saint Paul, MN, US

• 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.
• 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.
• Support or perform most aspects of new business and transfer business program/project management.

North Branch, Minnesota, US

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.
• 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.
• Successfully reversed failing contract manufacturing unit during first months and returned to Sales role.
• Managed Quality, Engineering, Production, Purchasing, Information Technology, and Sales.

• 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.

Rush City, MN, US

• 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.

Electronics Engineering Technician Ii, Electronics

Education record