Linda Boemer
Zimmerman,MN
Summary
Transformational quality and compliance leader in the medical device industry. I am experienced in developing organization's quality strategy, procedures, and processes. Monitor quality performance from supply chain and throughout product development life cycle. Proven success driving operational excellence, regulatory alignment, and team empowerment across global organizations. Known for shifting culture from reactive execution to proactive ownership through coaching, cross-functional collaboration, and strategic influence.
Manage quality audit program to identify and resolve non-conformities and embed culture of continuous improvement.
Overview
2026
2026
years of professional experience
Work History
Sr. Quality Engineering Manager
Abbott Medical
2022 - Current
Quality Engineering Manager
Abbott Medical
2020 - 2022
Site Quality Engineering Manager
Abbott Medical
2018 - 2020
Staff Quality Engineer
Abbott Medical
2015 - 2018
Education
Bachelor of Science - Business Administration And Management
Capella University
Minneapolis, MNSkills
- Led and developed cross-functional teams of 16 employees across quality control inspections, operations, supplier quality, sustainability of valve streams, new product introduction and quality assurance engineering
- Managed multimillion-dollar quality operations budgets
- Directed quality operations across two major Abbott sites
- Integrated 4 new product lines into existing QMS infrastructure 2 for Structural Heart BU and 2 for Electrophysiology BU
- Abbott rebranding
- Project requirement evaluation for brexit and EU MDR Compliance
- Quality planning -Facility Improvements, planned and unplanned environmental disturbances, relocation of product valve streams and decommissioning of product valve streams
- Quality assurance metrics -Presenting of monthly and quarterly analysis of quality metrics to executive level leadership
- Mentoring emerging leaders through the Abbott’s Professional Development and internship Program
- Championed culture transformation through coaching frameworks
- Corporate CAPA Approved Trainer
- Reduced nonconformance reports by 40% Reduced response and closure time by 50%
- Improved CAPA effectiveness by 20%
- QMS Harmonization & Process Improvement
- EU MDR Compliance
- Gemba walks and Kaizen events for lean transformation
- Product lifecycle management
- Six sigma methodologies
- Statistical process control
- Attention to detail
- Team leadership
- Non-conforming materials report
Affiliations
- Abbott Women in Leadership
- Abbott STEM program
- Safety Committee member
- Abbott Six Sigma Chairperson
- Minneapolis women leaders
Timeline
Sr. Quality Engineering Manager
Abbott Medical
2022 - Current
Quality Engineering Manager
Abbott Medical
2020 - 2022
Site Quality Engineering Manager
Abbott Medical
2018 - 2020
Staff Quality Engineer
Abbott Medical
2015 - 2018
Bachelor of Science - Business Administration And Management
Capella University
ADDITIONAL RELEVANT EXPERIENCE
Ametek-TSE
- Division Internal Auditor - Principal Quality Engineer
Arkray, USA
- Quality Assurance QMS, Regulatory Support Engineer
Medtronic – Neuromodulation
- Quality Assurance Manufacturing Engineer
Phillips Plastics/ Medsize Corporation
- Quality Assurance / Regulatory Consultant
- Program Management Office Developer
- Design Development Revision Specialist
- Quality Management System / Regulatory Compliance Assessment
Soligie INC
- Quality Assurance / QMS and Regulatory Manager
Core Competencies
- Audit Management
- New Product Introduction
- Risk Management FMEAs
- Process Development Validation (IQ, OQ, PQ, PPQ)
- Identification of key performance indicators for monitoring product quality, using data-driven analysis to drive improvements.
- Corrective and Preventive Action
- Supplier Change impact assessment
- Strategic Communication & Advocacy
- Cross-Functional Leadership & Coaching
- QMS Harmonization & Process Improvement
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