Quality Engineer

S COTT E. HAYWARD

* ** ****** ***** ***** H udson, WI 54016 6 12 - 229 - 0155 s **********@*****.***

E DUC ATION

UNIVERSITY OF MINNESOTA, TWIN CITIES INSTITUTE OF TECHNOLOGY, MAY 2008

Bachelor of Science in Biomedical Engineering Material Science emphasis

R ELEV ANT CERTIFIC ATI ONS A ND PROJECTS

ASQ CQE

ISO 13485:2003 Internal Auditor Training

Lean Manufacturing Training & Lean Event Facilitation

P ROFESSIONAL QUALIFICATIONS

Extensive contract manufacturing experience providing quality management and quality engineering

support for both internal and external medical device and aerospace customers

Effective inter-personal skills with the ability to develop strong working relationships with professional

staff and customers at all levels; strong written and verbal communication skills; detail oriented

Strong leadership skills with initiative required to accomplish team goals; comfortable working both

independently and as an integral team member

Ability to quickly adapt to new environments, responsibilities, and systems; organized and effective

project manager with the ability to prioritize and multi-task

Ability to apply Quality tools for true Root Cause Analysis: 5 Whys, Ishikawa, Pareto; CAPA system

expert

Strong blue print reading/GD&T knowledge with mechanical inspection experience (all hand tools,

optical comparator, vision systems/touch probe CMM)

MS Office, Minitab, and Design Expert (DOE)

E MPLO YMENT HISTORY

M icro - Matics, Inc. Quality Manager ( May 2 011 - June 2015 )

Fridley, Minnesota

Manage all aspects of company’s quality and shipping operations, including five direct reports

(scheduling, performance evaluations, discipline, temporary hires, etc.)

Manage and maintain ISO 13485 (medical device) and AS9100 (aerospace) registered QMS; Compile

monthly reports on Cost of Quality; facilitate and own the management review process

Primary customer contact for all quality related issues (engineering, development, complaints/RMA)

Manage and facilitate internal and external quality system audits

Manage and facilitate the CAPA system

Manage and facilitate training activities and maintain records

Manage and facilitate the PFMEA process and create all documentation required for PPAP submissions

(PSW, MSA (GR&R), CP, PF, FAIR) and internal quality plans

Review and approve customer POs ensuring customer requirements and internal business objectives are

met; review and approve ECOs/change management; obtain and control all external specifications

Procure all inspection equipment and tools for QA and manufacturing; manage calibration system

Manage and verify all raw material conformance (chemistry, DFARs, REACH, RoHS, Conflict Minerals)

Manage and maintain the ASL and all supplier quality issues; SCARS, credit, etc.

Manage and maintain the MRB system with cross-functional team

Create and implement Control Plans with SPC for quality assurance

M innesota Rubber and Plastics Quality Engineer II ( April 2010 - May 2 011)

River Falls, Minnesota

Provide Quality support for both project and manufacturing engineering, ensuring conformance to

customer specifications and internal QMS (ISO 13485 & TS16949 certified); support internal and external

audits

Review new prints for feasibility; oversee Gage R&R and implement associated Control Plans for new

products; set up SPC software files for data collection and analysis; create and approve Inspection

Instructions

Lead cross-functional teams in pFMEA development for process risk mitigation; assume ownership of

pFMEA for life of project

Address customer complaints and inquiries through CAPA system; review and evaluate effectiven ess for

CAPA; NCMR system maintenance; MRB team member; coordinate RMAs and return orders

Provide Supplier Quality support; review and approve incoming inspections for purchased components;

issue and manage SCARs

Member of Lean Steering Committee; facilitate Kaizen events in continuous improvement efforts to

address chronic issues; provide Report Out Summaries to management

Create molding and assembly Validation Protocols (IQ, OQ, PQ); evaluate executed results and present

Final Validation Reports for approval; execute DOEs as necessary for process validation(s)

P hillips Medica l Quality Engineer ( June 2008 - April 2010)

Menomonie, Wisconsin

Maintain CAPA system for complaints and participate in NCMR/MRB

Coordinate activities involved with internal and external approval of validations (IQ, OQ, PQ)

Documentation development and implementation including review and approval of ECOs, pFMEA, WI,

SOP, etc.

Participate in customer meetings during business reviews, designs reviews, redlines, etc.

Apply statistics to analyze process capabilities (DOE, SPC, hi/lo challenge, Gage R&R, etc.)

Development and implementation of statistical sampling/control plans; provide Quality support for

production

Manage supplier quality issues such as qualification, approval, incoming controls, and SCARS

Support cGMP/5S/customer/third party ISO audits

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