Laura Flessner

I Help Diverse Professionals Break Free Of Bias And Level Up Without Changing Who You Are // Ready To Do More, Be More? Register for my Personal Branding Masterclass, July 7 (free) -> Link in Featured Section

I help diverse professionals to break through unconscious bias so they can be seen, heard & valued. 

Essentially, I help you to be recognized as a leader in your organization, no matter your level, experience or role.

What is a diverse professional? Women, minorities, introverts, LGBTQIA+, neurodiverse… anyone who looks, sounds, or thinks different from others in the workplace. 

Is this you? 

It’s me. I’m a woman, Asian, an introvert, who looks really young. 

In past corporate roles, I felt frustrated, like I could do more, but I wasn’t always given the chance. The confusing thing was, I was getting fantastic feedback. 

There wasn’t any obvious bias or anything overtly intentional… but that didn’t change the fact that I wasn’t where I knew I could be. 

Unfortunately the traditional advancement system puts diverse professional at a disadvantage. Unconscious bias sneaks in, without people noticing - because it disguises itself as logic. 

It took me a while… but I found a way to break through - outside of the system. 

If the normal path to advancement:
- giving your all in quality work, 
- increasing your expertise, 
- directly asking for more

isn't allowing you to move forward... 

--> You need a different strategy. 

Transform what makes you “diverse” from a disadvantage to a superpower.  Your competitive advantage. 

I use neuroscience to help my clients break through unconscious biases their leadership and peers don’t even know they have. 

I use proven innovation tools and processes to help you to lead an idea, something you know will make a big impact, a meaningful difference. 

This strategy works at any level, in any industry, and at any organization.

Here’s 3 ways to work with me:

📚 Take a self paced course: Daring Different is a video based course with a step-by-step process to establish your authentic leadership. For the pre-manager and new entrepreneur. Go to: Thinkmindtap.com/daringdifferent

🚀 Join a live training cohort: Rise is a 8-week program where you will rise to your next level and people will notice a difference in you, guaranteed. For the committed pre-manager and new entrepreneur. Go to: Thinkmindtap.com/rise

🎯 Partner through coaching: Individualized guidance to create your next level of impact and personal power. For senior managers and business owners. Go to: Thinkmindtap.com/catalyst-coaching

It’s time for your voice to be heard. 
For your authentic leadership to be seen. 

Send me a DM (direct message) to explore your options!

💜 Laura

Founder & CEO

Be Recognized. Be Valued. Being You. 

Mindtap helps diverse professionals break through unconscious bias so their authentic leadership can be seen and valued using proven innovation techniques and applied neuroscience. 

Change how others see you, without needing to change who you are. 

Mindtap offers services for professionals at all levels, from entry to CEO. 

Reach out to explore how we can help you reach your next level of impact!

LinkedIn Online Training Courses

Rising Star Award 2023

DePuy Orthopaedics, Warsaw Indiana

Typical responsibilities and duties include:
•Thinks/works strategically and tactically, demonstrates a thorough understanding of linkages and relationships between individual quality subsystems. 
•Demonstrates leadership and possesses superior teamwork skills. 
•Leads and participates on teams providing quality systems and regulatory compliance expertise.
•Manages multiple projects in a fast-paced environment effectively prioritizing. 
•Regularly devise and implement methods and procedures for the monitoring, control and evaluation of quality systems, provides technical quality and regulatory compliance leadership.
•Independently monitors and analyze quality system and regulatory compliance data for the purpose of enhancing the suitability, efficiency and effectiveness of the quality system. 
•Demonstrates knowledge of and the ability to apply appropriate statistical techniques in various 
•Effectively manage Quality Management information systems, working proactively with system users in order to help them productively utilize these tools.
•Develop solutions to problems of wide scope/high complexity where erroneous decisions or failure to achieve results could have a significant adverse effect.
•Possesses superior knowledge of Good Manufacturing, Laboratory and Clinical Practices, expected to interpret and communicate GxP requirements to all levels of company.
•Thoroughly understand the audit process with demonstrated ability to lead and/or manage auditors in the performance of product, process or systems-focused audits. 
•Understand requirements and demonstrates the ability to maintain a quality system in a state of inspection readiness.
•Designs and delivers training on various quality systems elements to multiple audiences enhancing quality systems competence and compliance awareness.

Staff Quality Systems Engineer

Boston Scientific

•Responsible for conducting, and confirming follow-up actions on Corporate/Divisional/Site Compliance Audits.
•Planned and conducted requested audits of specific products, processes, or areas.  Included investigation, evaluation, and confirmation of follow-up.
•Responsible for working with QA management/teams on validations, protocol and process reviews, and implementation of requirements in compliance programs.
•Planned and conducted scheduled audits to assess compliance with FDA, ISO, MDD, and internal requirements.  Included audit scheduling, investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
•Participated in planning, coordination, and implementation of audit policies.  Included review of updated GMP/QSR regulations and current FDA and non-US requirements (ISO) and incorporation into internal programs where appropriate.
•Reviewed, understood and implemented changes related to ISO/GMP changes.  Included incorporation of this information into corporate and divisional programs through document reviews, protocol reviews, validation reviews, and training programs.
•Participated with Corporate and divisional QA on policy/procedure/ guideline development.  Included generation, review, and implementation of these documents.
•Worked with others to ensure that audit schedules were published on time and updated as appropriate.
Led training classes of Medical Device Regulations and Quality System Basics.

Sr. Quality Auditor

Medtronic Spinal & Biologics

Development, implementation and maintenance of the Quality Management System.  Some specific functional areas include Internal Audits, CAPA Management, Risk Management, Lead Projects, and Lead others as necessary.

Principal Quality Systems Specialist

Medtronic Spinal and Biologics

November 1999 to Present: Medtronic Sofamor Danek, 
As Manager of QA Systems (7/06 to 5/09) reporting to the Director of QA Systems, responsibilities include managing the Quality Systems Department, Quality System Continuous Improvement Process, Device Master Record Room, Document Control, Internal Audit System, Product Complaint Process and CAPA System.  I have 4 Document Coordinator employees, 1 CAPA, 1 Quality Systems Engineer, 1 DMR Supervisor reporting to me.  As Quality Systems Engineer (4/06 to 7/06), Supplier Quality Engineer Group Lead, (10/05-4/06)  my responsibilities included supervising 3 Supplier Quality Engineers.  Department and position were disbanded and transferred to Global Quality.
As Lead Quality System Auditor, (9/03-10/05) responsibilities included managing the Internal Audit function for the facility in Warsaw.  As Senior Quality Auditor, (11/99 – 12/00) responsibilities included developing, maintaining and documenting the Supplier Management Program.

Manager of QA/Systems

Triangle Rubber Company

Responsibilities included managing the QS-9000 Quality System, supervising the Laboratory and the Quality Department.  I had a degreed Chemist, a Senior Quality Technician, five Quality Technicians and a Process Technician directly reporting to me.  I was responsible any specific quality issues for three manufacturing plants, and a Corporate Office.  Responsibilities included Corrective Action responses both verbal and written, Preventive Action activities, Customer complaints, Internal Audit Management for all locations, PPAP submissions, APQP, Problem Solving and Statistical Techniques.  As the document coordinator for all policies, procedures, work instructions and forms, I developed an electronic document system to replace the previous manual system.  Performed employee training in PPAP, Statistical Process Control, Internal Auditing and the Quality System.  I coordinated and organized 3rd party audits, and served as the Management Representative.

Corporate Director of Quality

ASQ Michiana Section

Newsletter Editor

National Standard Company

Responsibilities were serving on the QS 9000 implementation team.  I visited the Plants to audit, and perform gap analysis of them against the QS 9000 standard.  In addition to this I taught problem solving techniques and internal auditing to plant Quality Managers and Quality Engineers.  Other duties included writing policies, procedures, work instructions and creating forms to comply with QS 9000 standards.  I have implemented and trained plant employees in new policies and procedures.   I have developed and implemented a quality auditor system, including trianing internal auditors; a customer complaint system and an SPC system.

Corporate Quality Engineer

Career oriented individual, with working knowledge of Worldwide Regulations, Standards and Quality Management Systems (QMS), currently employed as a Staff Quality Systems Engineer with DePuy Orthopedic in Warsaw Indiana.
Over thirteen years experience working in the Medical Device field, with expertise in Quality System Management, Corrective and Preventive Action, Internal Audit, Document and Data Control, Change Control, and Supplier Audits. Comprehensive understanding of MDSAP Regulations, ISO 13485, FDA (21 CFR Part 820), MDD (93/42/EC), Japan Pharmaceutical Affairs Law (Ministerial Ordinance 169, 2004), Brazil Resolution No 59 (ANVISA-Brazil GMP) and CMDR (SOR/98-282). 
Experienced  interfacing with Notified Bodies and FDA. 
Developed and implemented training programs for Internal Auditors.
Comprehensive experience establishing and managing compliance with current regulations and standards including, MDSAP Regulations, CFR 820, 211, CMDR, MHLW Ord.169, ISO-13485, ISO-9000. Demonstrated success in effectively managing quality departments and cross-functional teams to assess, develop and implement quality management systems in a collaborative manner. Authored and implemented QMS documentation. Expertise includes: 
•Manufacturing / Process Controls
•Design, Supplier and Controls
•Corrective and Preventive Action
•Quality Management Systems and Audit Processes 
•Process, Metrics/Data Analysis
•QMS Requirements and Auditing Instructor 
•Project Management

Motivated team player with demonstrated talent for deploying Quality & Regulatory requirements, quality tools, and upgrading and streamlining of processes. I am an enthusiastic self-starter who can boost productivity, foster efficiency, develop and deploy strategy for effective Quality Management Systems.

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Laura Flessner

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