Mark Bird Email & Phone Number

Longmont, Co, Us

Center Valley, Pennsylvania, Us

Mergers and Acquisitions focusing on complaint processes, gap analysis and process improvement. Involvement and ownership in the Corrective and Preventive Action (CAPA) Process relating to complaints.

Minneapolis, Mn, Us

A seasoned quality engineering leader with a strong cross-functional background in Supplier Management, Supplier Quality, Risk-Based Controls, Design Quality, Design Transfer, Process Validation, Component Qualification, Auditing, and Negotiation. A detail oriented and multi-tasking project lead who is accountable and has a history of collaboration and breaking down barriers, while meeting timelines, deliverables and commitments in the Medical Device Industry. One who is passionate in working with cross functional teams and suppliers, and is accustomed to working in a fast-paced and multi-faceted environment.* Successful and on-schedule implementation of risk-based supplier controls including Quality Management System (QMS) maintenance, procedure updates, collaboration, obtaining buy-in across functional disciplines, and training. Completed project five months ahead of schedule.* Recognized by management and peers as the Subject Matter Expert (SME) on procedures and compliance within the Supplier Quality Engineering and Quality Organizations.* Owned and managed Supplier Corrective and Preventive Actions (CAPA) with excellent Root Cause Analysis (RC) and Corrective/Preventive Action (CA) skills; achieved 100% first-pass success on obtaining CAPA Board approvals for supplier RC/CA.* Pro-actively identified and implemented process improvements for First Article Inspection (FAI), supplier certification program, and supplier monitoring. Improved supplier monitoring key performance indicator (KPI) efficiency by ~65%.* Identified workmanship related trend failure at computer system manufacturer and successfully managed supplier and issue. Increased the supplier quarterly rating from 25% to over 93% within a four-month period.

Internal Quality Engineer on development projects responsible for all aspects of quality including quality record review and approval of Design History File (DHF), Validation Protocols, Validation Reports, Engineering Change Orders, Design FMEA, and Safety Risk Management/Hazard Reviews associated with New Product Development and Design Transfer.

Management of two simultaneous $4M programs while balancing priorities and competing for internal resources; Leading a cross-functional team to meet contractual commitment and deliverables; Active involvement with NCMRs and member of Failure Review Board utilizing fault trees, fishbone diagrams, and recommending path forward; Daily interaction with and management of Customer and expectations; Sub-contract management of sub-tier supplier.

Us

* Program management & tracking, preparation of weekly status for presenting issues & highlights to the Executive Management Team* Successfully planned & managed test activity/resources allowing multiple programs to run through qualification process simultaneously without interruption to schedule* Coordinated all qualification & test activity (environmental, shock & vibration, ESD/EMI susceptibility), analyzed data, verification of design spec * Communicated and negotiated Reliability & Test Qualification interests while meeting schedule & deliverables required by Program Management Team* Demonstrated ability working with individuals at all levels, across multiple disciplines, and being open-minded to differences of opinion while resolving conflicts and leading a cross-functional team* Ability to multi-task and balance priorities, meet commitments and customer expectations, highly accurate thorough work, excellent communication, follow-through and closing skills

Us

* Successfully managed Corporate Japanese Partnerships (Sony, Hitachi, Matsushita) from a technical, quality, and business perspective and negotiated major contracts including* Media Supply Agreement resulting in reduced cost and savings of $1M annually* End-of-Life Component Agreement reducing repair part inventory risks up to 50%* Material forecast, scheduling, and management of roughly $8M annually* International travel and cross-cultural sensitivity with moderate level of spoken Japanese* Interaction with Sales/Marketing managing OEM, VAR, and Distributor Channel Inventories* Proven record of accepting new assignments and handling increased responsibility

Us

* Department Manager both hourly & salaried personnel (20) including Supplier Quality, Sustaining Engineering, & Receiving Inspection functions* Supported Development Engineering with quick-turn PCBA & hardware system proto-types throughout development cycle* Increased efficiency of incoming inspection, reducing average time from 17-days to 7-days through scheduling, leveraging supplier Cpk process data, & focusing on problematic areas* Active member of Material Review & Change Review Board & disposition of discrepant material identifying ways to reduce scrap* Increased quality levels through pro-active approach, awarded $5000 bonus based upon suppliers meeting established quality goals and deliverables* Primary interface to Solectron, PCBA manufacturer, analysis of PCBA and design for manufacturability (DFM)* Facilitated engineers in understanding new & upcoming PCBA technologies and manufacturing processes* Familiarity with ICT, Functional, and HALT test fundamentals