Senior Quality Engineer Medical Device Suppliers

JO PIKE

Dunedin, FL 248-***-**** ********@*****.***

Senior Quality Engineer Supplier Quality Medical Devices

PROFESSIONAL SUMMARY

Senior Quality Engineer with 15+ years of experience in medical device manufacturing, supplier quality, and global transfer programs. Expertise in PPAP/SPPA, APQP, special process validations (IQ/OQ/PQ), and supplier remediation for Tier 1 and Tier 2 suppliers. Proven ability to support regulatory compliance, new product launches, and supplier development initiatives.

CORE SKILLS

Supplier Quality Engineering, PPAP, SPPA, APQP, IQ/OQ/PQ, Special Process Validation, PFMEA, Control Plans, Risk Management, Supplier Audits, Change Management (SCR), Global Transfers, Medical Device Quality Systems, MSA, CPK, SPC, GD&T, Minitab, CMM, Cross-Functional Leadership

PROFESSIONAL EXPERIENCE

Black Diamond Network (Contract) – Johnson & Johnson Supplier Quality Engineer Jan 2019 – Mar 2021

- Supported global knee replacement surgical robot development program

- Reviewed supplier quality files for compliance with corporate quality requirements

- Led Tier 1 and Tier 2 special process validation reviews including IQ/OQ/PQ

- Approved PPAP documentation including Control Plans, PFMEAs, MSAs, FALs, and validation evidence

- Coached suppliers to close documentation and compliance gaps

- Represented Supplier Quality on global transfer teams (US and Europe)

Zimmer Biomet Senior Quality Assurance – South Region (Remote Consultant) May 2017 – Sep 2018

- Managed quality oversight for 20 suppliers

- Reviewed and approved Tier 1 and Tier 2 special process validations

- Ensured timely completion of IQ/OQ/PQ documentation

- Conducted supplier site reviews as required

Tecomet Inc. Quality Engineer (Contract) 2015 – May 2017

- Led part transfer projects associated with plant closures

- Created OEM-required transfer documentation

- Performed MSA and CPK analysis on critical characteristics

Zimmer Biomet Senior Quality Engineer – Supplier Quality (Contract) 2014

- Supplier Quality oversight for 64 suppliers

- Reviewed and approved SPPA and PPAP documentation

- Managed supplier change requests through formal change management systems

- Developed standardized SPPA training materials for suppliers

Tecomet Inc. Process Quality Engineer 2011 – 2013

- Supported APQP and launch activities for 20 customers

- Developed inspection plans, control plans, and launch documentation

- Managed MRB activities, NCRs, SCARs, and customer returns

- Served as Quality representative for Ireland plant startup initiative

CERTIFICATIONS & EDUCATION

ASQ Certified Quality Engineer (CQE)

ASQ Certified Quality Technician (CQT)

University of Phoenix – Business Management

University of Indianapolis – Business Management

TECHNICAL TOOLS

Minitab, CMM (CMES, LKDMIS, Camio), SPC, GD&T, Microsoft Excel, Word, PowerPoint, Access

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