Process Engineer Quality Assurance

COLEEN FOX

Biomedical Engineering ● Aerospace ● Biotech ● Process Engineer

Denver, CO - ******@***.*** - https://www.linkedin.com/in/coleen-fox-65437469/ SUMMARY OF QUALIFICATIONS

Process improvement enthusiast with a Yellow Belt certification and experience solving challenges in highly regulated bio- medical engineering, aerospace, and biotech industries. Proven success in quality assurance, process improvement, and cross- functional collaboration. Adept at managing compliance with ISO and FDA standards to improve product quality and opera- tional efficiency. Passionate about creating impactful solutions that enhance productivity and reliability.

• Advanced knowledge in quality systems: ISO 9001, ISO 13485, and IATF 16949 standards.

• Strong process control skills: Design validation, process control, and CAPA implementation.

• Technical expertise: SolidWorks, MATLAB, and statistical analysis tools for product development and quality testing.

• AI and machine learning applications: Quality improvement and operational analysis. PROFESSIONAL EXPERIENCE

SENIOR OPERATIONS QUALITY AND PROCESS ENGINEER

Medtronic, Broomfield, CO - Apr 2024 - Aug 2024

A global leader in medical device manufacturing technology with 95K employees and $30B revenue. Held 4-month contract help- ing a manufacturing and warehouse team reduce bottlenecks. Improved documentation and testing processes to recertify re- furbished medical carts. Reported to Senior Manufacturing Operations Quality Assurance Manager.

• Improved compliance and Process efficiency: Developed and maintained quality protocols for material processing in GMP environments, designed inspection mechanisms to ensure ISO 9001 and ISO 13485 compliance, and coached manufacturing engineers to implement corrective actions (CAPA).

• Enhanced collaboration across teams: Partnered with cross functional engineering and manufacturing teams to establish robust quality standards and streamlined workflows in medical device manufacturing.

• Implemented data-driven process improvements: Conducted statistical analyses to evaluate product reliability and identified cost-effective corrective measures to improve medical cart workflow and efficiency. PRODUCT ENGINEER

DataAnnotation Tech, Denver, CO (Remote) - Sep 2023 - Present A tech firm that specializes in AI and machine learning model training and providing high-quality data labeling services. Perform seasonal contract work to improve AI model performance through quality assurance and response refinement.

• Enhance AI model accuracy and trustworthiness: Analyze AI-generated responses for reasoning, processing capa- bilities, and factual accuracy to ensure well-structured and reliable outputs.

• Refine AI response style: Rewrite and adjust responses to enhance readability, organization, and trustworthiness while mitigating bias and controversial topics.

• Improve AI ethical guidelines: Train AI models to produce positively phrased results, recognize inappropriate que- ries, and implement appropriate rejection responses to reduce misinformation and hate speech PROCESS QUALITY ENGINEER

Mag Specialties Inc., Denver, CO - Nov 2021 - Feb 2023 A leader in magnesium and metal extrusion products, with 200 employees and $20M revenue. Designed and implemented quality asurance program, internal & external auditing, and documentation systems firmwide. Reported to VP of Quality.

• Enhanced quality systems for metal extrusion: Managed quality systems within a multi-lingual setting for metal extrusion operations, driving customer satisfaction through effective CAPA processes, conducted ISO 9001:2015 com- pliance audits, and implemented data-driven solutions to identify trends and recommend process improvements.

• Improved processes and compliance: Developed and modified process formulation, methods, and statement of pro- cedures (SoP). Drove finite elemental analysis (FEA) to improve reliability for $5B customer.

• Product Development and cost analysis: Reviewed product requirements for processing compatibility as part of key customer production part approval process (PPAP). Analyzed trends and test methods for testing metal compo- nents including airplane seats, truck shelving, and power tools to ensure durability and industry compliance.

• Streamlined audit readiness: Established pre-audit processes and protocols for internal and external audits across all production functions, reducing preparation time and further enhancing compliance. COLEEN FOX Page 2 of 2

SENIOR QUALITY ENGINEER

Abbott, Denver, CO (Remote) - Oct 2020 - Oct 2021

A global healthcare company with more than 113K employees and $43B revenue. Worked 12-month remote contract as part of the Los Angelos-based team to ensure regulatory compliance and legacy product quality maintenance.

• Harmonized global quality standards: Performed gap assessments for multiple product lines to align with China medical device regulations (MDR), reviewed risk management documents, and collaborated with cross-continental teams to implement corrective action updates and quality improvements.

• Improved risk management: Provided detailed risk analysis for product development and regulatory compliance.

• Supported global compliance efforts: Helped Chinese teams align quality protocols with U.S. F.D.A CFR 820 & CFR 821, and ISO 13485 standards for component validation and market access. Validated new materials to meet updated process specifications.

SENIOR QUALITY ENGINEER

Zimmer Biomet, Denver, CO - Nov 2019 - Mar 2020

A global leader in musculoskeletal healthcare with 20K employees and $7B revenue. Contracted 4 months, contributing to up- dates of Design History Files (DHF) for major product lines. Reported to Senior Quality Engineer.

• Ensured compliance with EU and MDR standards: Reviewed and updated Design History Files for four major prod- uct lines, aligning with EU Medical Device Directive and Medical Device Regulation (MDR) requirements.

• Supported risk management: Conducted risk assessments and reviewed Design Input/Output Matrices for accuracy and compliance.

• Facilitated legacy file harmonization: Collaborated with cross-functional teams to provide input for the harmoniza- tion of legacy documents.

QUALITY ASSURANCE ANALYST

Cognizant Technology Solutions, Allentown, PA and Chicago, IL - Jul 2016 - Jul 2019 A multinational technology company with 330K employees and $19.4B in revenue. Worked with 8-25 person teams to help phar- maceutical companies create quality documentation systems and processes. Reported to Client Relations Manager.

• Executed FDA-compliant software validations: Produced quality documentation related to information (IQ), opera- tional (OQ), and performance (PQ) for FDA-compliant software development projects, conducted validation and verifi- cation of the shipping website for a $20 billion company, and developed technical documents and training materials to help Chief Information Officer streamline workflows.

• Enhanced software reliability: Conducted rigorous test protocols to find and resolve product defects. PRODUCT DESIGN ENGINEER

Arizona State University, Tempe, AZ - Aug 2015 - May 2016 A leader in interdisciplinary research and education. Served as a design engineer.

• Engineered FDA-compliant prosthetics: Designed and tested mechanical devices, including prosthetics, using DOE and FMEA methodologies to implement FDA-compliant design and manufacturing processes. EDUCATION

• Bachelor of Science in Engineering, Biomedical Engineering - Arizona State University CERTIFICATIONS

• ISO 9001:2015 Lead Auditor - Cavendish Scott, 2022

• Certified Yellow Belt - GoLeanSixSigma.com, 2021

• PPAP-Production Part Approval Process, 2022

• Certified SolidWorks Professional - SolidWorks, 2014 SKILLS

Quality Systems Management (ISO, FDA, EU Regulations) ● AI and Machine Learning Applications ● Statistical Analysis and Root Cause Analysis ● SolidWorks, CAD, MATLAB, C++ ● Process Improvement and Validation ● Technical Writing ● Risk Manage- ment ● Creative Problem Solving ● Basic Language Proficiency in Spanish and German PROFESSIONAL AFFILIATIONS

• Active Member, Society of Women Engineers (SWE)

• Alumni Association, Arizona State University

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