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Steven Skroch

@stevenskroch

Quality Engineer at Antech Diagnostics improving diagnostic assay reliability through Statistical Process Control.

At Antech Diagnostics, I lead cross-functional root cause investigations into complex diagnostic device failures and coordinate CAPA responses across departments. I also partnered with R&D as the Design Quality representative for five new product introductions.

I implemented Statistical Process Control on 33 diagnostic laboratory assays and advocated for resources to revise QC processes and increase assay reliability. I also designed and implemented a supplier quality program to address manufacturing and measurement issues.

At Seagate Technology, I developed a cumulative-return-rate metric using Python and SQL to improve field-reliability visibility and customer-issue prioritization. Across my quality roles, I’ve supported audits and certifications including AS9100, ISO 9001, and ISO 13485.

Experience

Work history, roles, and key accomplishments

Current

Senior Quality Engineer

Current

Antech Diagnostics

Dec 2023 - Present (2 years 10 months)

Served as the sole Quality Engineer for nine months, leading cross-functional root cause investigations and developing team leadership to manage complex CAPA responses. Partnered with R&D on new product introductions and implemented Statistical Process Control on 33 diagnostic laboratory assays.

Root Cause Analysis 5 Whys Fishbone (Ishikawa)Fault Trees Process Mapping Is Is Not Analysis CAPA D P FMEA PFMEA Hazard Assessments Statistical Process Control Supplier Quality Supplier Corrective Action Requests

Quality Engineer

ARC Group Worldwide, Inc.

Aug 2023 - Nov 2023 (3 months)

Established an internal audit system to maintain AS9100 certification and guided inspection technicians on best inspection methods and statistical methods for aerospace mechanical components.

AS9100 Internal Audit Inspection Techniques Statistical Methods

Customer Quality Engineer

Seagate Technology

Sep 2021 - Jun 2023 (1 year 9 months)

Led critical conversations with customers to highlight quality successes and built trusted partnerships to influence CAPA corrective actions and customer-complaint investigations. Developed a cumulative-return-rate quality metric using Python and SQL.

Customer Quality CAPA Python SQL Data Analysis Field Reliability

Quality Engineer

MultiSource Manufacturing LLC

Jun 2019 - Sep 2021 (2 years 3 months)

Escorted external auditors to maintain ISO 13485 certification and led customer audit engagements, providing detailed responses to auditor inquiries.

ISO 13485 Audit Customer Audits

QA Internal Auditor

Sierra Nevada Corporation

Dec 2016 - Jun 2019 (2 years 6 months)

Conducted 25+ internal quality audits to maintain AS9100 and ISO 9001 certification and improved manufacturing processes for spacecraft by rewriting obsolete processes.

AS9100 ISO 9001 Internal Audit Process Improvement

Quality Engineer

Sierra Nevada Corporation

Oversaw process quality and supplier source inspections for docking modules for the International Space Station, and evaluated suppliers for approval on the Approved Supplier List.

Supplier Quality Source Inspection AS9100 Supplier Audits