Supplier Quality Engineer, Senior Quality Engineer

Daniel Joseph Derleth

*** ****** ***** **** - *********, New York 14622-1741 –

H: 585-***-**** Cell: 585-***-****

************@***.***

http://www.linkedin.com/in/danielderleth

Develop and maintain effective working relationships with suppliers and manage supplier onboarding activities, supplier-related changes, and provide supplier quality oversight via supplier monitoring activities to meet established criteria to drive ISO 13485:2016 and ISO 9001:2015 regulations to support the Quality Management System (QMS) for manufacturing. Collaboratively resolve company and supplier nonconformances using risk management tools to ensure adequate RCIs are conducted and effective CAPAs are implemented. Execute protocols to address nonconformances, product dispositions, root cause investigations, and implement appropriate CAPA based on risk level. Striving to identify opportunities to improve quality and cost that are aligned with the overall business goals utilizing strong problem solving and communication skills.

Core competencies include:

o ISO 13485:2016 Lead Auditor

a.) Medical Devices Quality Management Systems ISO 13485:2016; FDA QSR 21 CFR 820

b.) Management Systems Auditing (ISO 19011:2018)

o Certified RABQSA Lead Auditor 9001:2000

o Certified OHSAS 18001 / 14001 Training

o Certified OEM Lean Manufacturing

o Working knowledge of APQP methodologies

o Broad knowledge in the theory and principles of FMEA, PPAP, CAPA, DMAIC

o SAP Enterprise Resource Planning (ERP)

o TrackWise QMS software

o Microsoft Office (Word, Excel, PowerPoint), Outlook, Minitab, Visio

Professional Experience:

Senior Supplier Quality Engineer Sept 2021 – Oct 2022

Rochester Precision Optics

• Establish processes, protocols, and documentation for Supplier Management activities. Develop Quality Agreements to ensure adequate supplier control plans are implemented, documented, and maintained and to oversee supplier monitoring activities.

• Investigate and implement best practices for creating partnerships and establishing processes to ensure that incoming product specifications contain and clearly communicate the requirements needed to ensure supplied products are acceptable for manufacturing and assist in the development of and changes to inspection methods and sampling plans for materials and components.

Senior Supplier Quality Engineer Apr 2021 – Sept 2021

Cantel Medical / HuFriedy Group

• Provided Supplier Quality Engineering support to address manufacturing quality events establishing onboarding activities and Supplier controls to ensure capabilities are met to meet specifications.

• Worked with Commodity Managers to review and approve Engineering Change Orders (ECO), Deviation Authorizations, Qualification/Validation Protocols, Final Qualification Protocol Reports, as well as Inspection Procedures related to supplied components.

Senior Quality and Supplier Engineer Sep 2020 – Apr 2021

Ortho Clinical Diagnostics

• Partner with operations to evaluate to address manufacturing quality events including nonconformances, product dispositions (PD), root cause investigations (RCI), and implement appropriate CAPA based on risk.

• Work with suppliers to ensure nonconformances are addressed, comprehensive RCIs are executed, effective CAPAs are implemented, and adequate Supplier controls (bounding, containment) are in place. Senior Supplier Quality Engineer

Supplier Development Engineer, 2019 – 2020

LSI SOLUTIONS®, Inc.

• Function as a liaison between suppliers and internal cross-functional groups (Engineering, Quality, Operations, Supply Chain, etc.) to clarify requirements, facilitate communication and drive accountability for improvement actions. Assure regulatory compliance of manufactured components and processes as well as coordinating on-boarding activities and compliance to ISO 13485 / FDA QSR 21 CFR requirements.

• Execute the Production Part Approval Process (PPAP) with HIGH and MODERATE risk suppliers using Minitab, Process Capability, Process Control Plans, Process Flow Diagrams and Failure Mode and Effects

(FMEA) tools.

• Spearhead supplier sourcing and development to ensure vendor capabilities, contract expectations, and that quality and delivery goals are achieved.

• Participate in root cause investigations of non-conforming material or special projects focusing on positive collaborative relationship with supplier and LSI’s Quality, Engineering, and Supply Chain.

• Provide coaching/training to suppliers as needed based on audits/assessments to improve processes and reduce risk of quality non-conformance.

Supplier Quality Engineer, 2017 – 2019

LSI SOLUTIONS®, Inc.

• Working with the LSI supplier base in a collaborative partnership as a liaison to provide components of the highest quality and workmanship.

• Revamping the LSI supplier quality management system aspiring to ISO 13485:2016 risk-based processes to include Supplier Quality Agreement, Supplier Evaluation, Supplier Approval, Purchasing Methods, Supplier Risk Classification and Guidelines, and Supplier Corrective Action Request (SCAR) documentation.

• Auditing of LSI’s high and moderate risk suppliers to ensure compliance to the ISO 13485:2016 standard and FDA 21 CFR 820 regulations.

• Collaboratively work with supply chain to improve supplier relationship management driving accountability for process improvements.

Project Quality Leader / Global Supplier Quality Engineer, 2006 – 2017

Eastman Kodak - Consumer Digital Imaging Group – Retail Systems Solutions (RSS)

• Orchestrated and delivered on a corporate wide effort to train 300+ RSS personnel across multi-functional groups transitioning from an antiquated issue tracking system to Jira with little to no impact to current operations.

• Drove delivery of all required elements between Product Design and Supplier Manufacturing using the Quality Management Plan (QMP) with overseas suppliers.

• Rochester Institute of Technology

Course Concentration: Biomedical Engineering, no degree

• State University of New York, College of Environmental Science and Forestry Degree: B.S. Environmental Science.

• Monroe Community College

Degree: A.S. Environmental Studies.

Professional Development Certificates:

ISO 13485:2016 Lead Auditor Certification – 10/2018

- Medical Devices Quality Management Systems ISO 13485:2016

- Management Systems Auditing (ISO 19011:2018)

Medical Device Supplier Quality Management Training 8/2018 OEM Lean 101 Certification

Integrated HSE ISO 14001 & OHSAS 18001

RABSQA 9001:2000 QMS Lead Auditor Certification

Education & Training

Contact this candidate