Quality Assurance Manager Resume - Sarah Johnson

Professional resume for QA Manager specializing in medical device manufacturing.

Sarah Johnson

+1 (555) 678-9012 sarah.johnson@email.com 10years Birth Date: 1988-08-25 female

Job Intention

Desired Position	Quality Assurance Manager (Medical Devices)
Expected Salary	$130,000 - $165,000
City	Minneapolis, MN

Self Evaluation

Accomplished QA leader with 10 years of experience ensuring regulatory compliance for Class II and Class III medical devices. Expert in ISO 13485, FDA QSR, and risk management (ISO 14971). Successfully led 3 FDA audits with zero 483 observations. Reduced customer complaints by 60% through CAPA excellence. Six Sigma Black Belt with strong focus on continuous improvement.

Work Experience

Medical Device Manufacturer

2020-07

Department: Quality

Senior Quality Assurance Manager

Lead quality organization for $500M cardiovascular device division. Manage team of 15 QA engineers and technicians. Oversee design controls, supplier quality, and manufacturing QA. Achieved 99.5% first-pass yield through process validation improvements. Maintained zero recall rate for 5 consecutive years.

Healthcare Company

2017-05 - 2020-06

Department: Quality Assurance

Quality Manager

Managed quality system for orthopedic implant product line. Led internal audits and supplier assessments. Implemented CAPA system reducing recurrence by 70%. Supported 510(k) submissions and PMA applications. Trained 200+ employees on quality procedures.

MedTech Company

2014-08 - 2017-04

Department: Quality

Senior Quality Engineer

Developed validation protocols for manufacturing processes and test methods. Investigated customer complaints and led root cause analysis. Created statistical process controls monitoring critical parameters. Supported new product introductions ensuring design transfer readiness.

Project Experience

FDA Inspection Readiness Initiative

2023-02 - 2023-10

Quality Lead

Led comprehensive FDA inspection readiness program preparing for routine surveillance audit.

Responsibility Gap assessment, remediation planning, mock audit, team training, audit facilitation, commitment tracking.

Achievement Passed FDA audit with zero 483s. Ranked in top 5% of facilities audited that year.

Customer Complaint Reduction Program

2022-05 - 2022-12

Project Lead

Implemented systematic CAPA improvement program addressing top complaint drivers.

Responsibility Data analysis, cross-functional investigation, corrective action implementation, effectiveness verification.

Achievement Reduced complaint rate by 60%. Saved $5M in potential warranty costs.

Education

University of Minnesota

2012-09 - 2014-05

Master of Science , Biomedical Engineering

GPA: 3.8/4.0.

Purdue University

2006-09 - 2010-05

Bachelor of Science , Chemical Engineering

GPA: 3.7/4.0. Magna Cum Laude.

Skills

ISO 13485 & FDA 21 CFR Part 820 Risk Management (ISO 14971) CAPA & Root Cause Analysis Process Validation & IQ/OQ/PQ Statistical Analysis (Minitab, JMP) Auditing (Internal & Supplier)

Certificates

2023-06

Six Sigma certification

2022-09

Quality auditing certification

2021-05

Regulatory affairs certification

Highlights

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Template Info

RegionUS

Categoryhardware

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