SUMMARY

• 17 years’ experience designing, implementing and managing corporate quality systems:
• Implemented Motorola’s new corporate strategic programs into startup organizations, including: QS9000, Enterprise Management, Matrix Management and Program Management.
• Designed and implemented ISO13485 and cGMP compliant systems into KeyTronic’s contract manufacturing organization for successful certification in US and Mexico.
• Managed Takata’s corporate ISO/TS16949 and Supplier Quality systems in Confidential local automotive air - bag manufacturing site.
• System Owner for Internal Audit, Document Control, NCR/MRB and CAPA systems; creating programs, training and managing compliance.
• Five years’ project management experience: -Managed timelines and tasks for Diffusion/CVD area of $30MM new-factory startup. -Lead 20 teams to implement quality systems into startup organizations. -Project Management Facilitator; trained to assist teams in the use of standard PM tools, such as: Team-Building, Gantt Charts, Critical Path Analysis and Risk Analysis.
• Transferred $30MM Class II Medical Device program from Germany into contract-manufacturing in Mexico; responsible for quality and regulatory compliance, manufacturing quality, and extensive integration of customer, supplier and factory needs.
• Excellent trouble-shooting skills and ten years’ hands-on process support of complex processes in ISO4 cleanrooms.
• Strong analytical ability and experienced with excel pivot tables and Minitab, DOE’s, ANOVA’s, GR&R, Process Validation and SPC, Process Mapping and FMEA’s, CAPA implementation and management.
• Highly collaborative with excellent communication skills; capable of training and writing procedures, protocols and reports for all organizational levels.

WORK HISTORY

Confidential, Ann Arbor, MI

Responsibilities:

• Reviewing existing process documentation, FMEA’s, CAPA’s, DHR’s and audits.
• Working with Chemists and Statisticians to design screening DOE’s and TMV’s
• Analyzing and reporting results, obtaining x-functional team input and approvals.
• Process Validation planning, training, implementation, analysis and reporting.

Confidential, Spokane Valley, WA

Senior Quality Engineer

Responsibilities:

• Responsible for ensuring quality and regulatory compliance of Medical Device programs at KeyTronic Corporation, a fast-pace and growing contract manufacturer, with Injection Molding, Printed Circuit Board Assembly (pcba) and Final Assembly (Box Build) operations and factories in US, China and Mexico.
• Transferred Class 2 Medical Device programs from Braun’s factory in Germany to KeyTronic’s factory in Mexico; demanding extensive collaboration with multi-national teams of customers, suppliers, auditors and manufacturing sites.
• Designed, implemented and integrated cGMP compliant systems into existing QMS; assisting with and successfully passing P&G’s QAKE system audit, ISO13485 certification and FDA audits.
• Managed qualification and validation for 510K submission:
• Directed DQ testing; reviewed results, wrote and submitted test reports.
• Designed validation plans (IQ, OQ, PQ), coordinated testing, reviewed data, resolved deviations and discrepancies, wrote and submitted reports.
• Directed all CAPA activities for medical device program; utilizing 17 years of CAPA ownership and 10 years hands-on process engineering experience to ensure quick action and effective issue resolution:
• Point of contact for all customer complaints and auditor findings, clarifying problem statements and initiated immediate containment (Stop Ship/Stop Build).
• Collaborated with suppliers, factories and customers as needed to facilitate formal root cause analysis for occurrence and escape, ensured CAP’s were actionable, issues resolved and effectiveness validated prior to closure.
• Transitioned team to new corporate CAPA system, with defined ownership based on Fishbone analysis, documented approvals and verifiable effectiveness audits.
• Initiated use of the FMEA Risk Assessment tool for prioritization and approval of CAPA’s, implemented the process and trained the organization.
• Reviewed and approved all changes to BoM’s, drawings, procedures, materials and suppliers.
• Reviewed customer change requests and supplier requests for material changes.
• Designed and negotiated validation plans, directed validation activities, submitted reports and implemented the approved changes.
• Defined, validated and implemented extensive internal rework processes over a 5 month period, resulting in recovery of $6MM of NCM.
• Modified lot tracking process multiple times to comply with customer requirements from EU, AP, KO, CA and AU. Provided process maps for approval, directing validation and implementation activities and implementing final processes.

Confidential, Moses Lake, WA

Responsibilities:

• Managed Document Control and Internal Audit systems (11/04-5/06)
• Responsible for incoming material qualifications, supplier audits, and SCAR management. (5/06-5/07)
• Trained Environmental (EMS) auditor and AIAG certified Supplier Auditor

Confidential, Mesa, AZ

Responsibilities:

• Directed activities of 20 quality system champions and their teams; provided auditing for gap analysis for ISO conformance and functioned as a critical interface between the key stakeholders: corporate program managers, site staff, project teams and factory employees.
• Became certified PMM (Project Management Master). Provided team facilitation training to staff and project managers to optimize early successes and remove roadblocks.
• Restructured a poorly functioning “Scrap Team” into a highly effective “CAPA Team” by integrated core tools (FMEA, 8D, 6M Fishbone and Enterprise Management) to eliminate non-critical CAR’s and reduce cycle-time for new Corrective Action Plans to 10 days.
• Fishbone - Because each “M” in the 6M process is linked to a defined manager who has goals, metrics and resources linked to company objectives.
• FMEA and 8D - Provided managers with the tools to define risks and opportunities in a predictable method, to leverage training and maintain the resulting knowledge and experience in an accessible format for future use.
• the knowledge and escalating and resources to problems to Assign
• Designed and implemented an improved Change Action Board process that allowed new and substitute members to decide if a validation was successful and move forward without extensive questioning, re-debate of concepts and the stressful uncertainty of success when presenting the results long term projects.

Confidential, Mesa, AZ

Startup Team Leader

Responsibilities:

• Diffusion/LPCVD Project Manager and SME for US and China semiconductor dirt-to-production startup.
• Managed timelines for supplier, facilities and production team activities.
• Selected, installed, validated, and sustained Diffusion/CVD equipment and processes.
• Resolved a number of complex startup process issues by being creative and determined.Backmetal, Evaporative Au, PVD Ti, Ti/W and Pt, Anneal and Sinter furnaces.
• Diffusion, LPCVD, APCVD, Plasma CVD and acid cleaning process support.