KATHERINE MINDISH
Hillsborough,NJ
Summary
Senior management professional, bringing strategic leadership and operational excellence to drive organizational success. Skilled in project management, team collaboration, and process optimization with keen focus on achieving results. Adept at navigating complex challenges, fostering culture of accountability, and adapting to evolving business needs. Known for strong decision-making, effective communication, and building high-performing teams.
Overview
29
29
years of professional experience
1
1
Certification
Work History
Sr. Manager, Quality Engineering
Ethicon
Raritan, NJ
11.2021 - Current
- Direct a global team of Quality Engineers including resource planning, hiring, training & development, assignment planning and performance evaluations.
- Voting member of the Product Quality Safety and Surveillance team assessing product quality complaints and delegate for Risk Management Board, Product Dispositions and Stagegate Project review forums.
- Developed a strong company culture focused on employee engagement, collaboration, and continuous learning opportunities.
- Provide guidance to project teams and other subject areas to ensure compliance with company policies and procedures as well as appropriate regulations in addition to hosting external regulatory audits.
Manager, Product Management
Ethicon
Somerville, NJ
03.2019 - 10.2021
- Lead a NPI project that was part of a transformational program (top 35 NPI project across all of MD) as the Global Tech Ops program manager, which includes capital appropriation requests of $6MM and creation of a global supply chain for an innovative product to alleviate pain through a non-opioid alternative.
- Developed business plans, hired and managed project leads and resolved technical problems while partnering with Source, Supply Chain, Quality and R&D to drive project Clearwater for Ethicon, Inc, Cost Improvement Program for procured direct materials, components and finished goods targeting over $10MM in savings.
- Lead a material supplier transfer project supporting $500 MM business of antimicrobial suture line. Lead planning meetings with multiple cross functional attendees and global supplier to frame all work streams.
Staff Quality Engineer
Ethicon
Somerville, NJ
02.2016 - 03.2019
- Aligned all process validation procedures including test method validation across all J&J MD sector which includes Ethicon Inc, Ethicon Endo, Mentor, BWI and ASP for a total of 54 sites. This project harmonized, standardized, and simplified requirements while maintaining regulatory compliance.
- Implemented multiple design changes on commercially available gynecological and surgical drain medical devices.
- Facilitated Wound Closure and Gynecological Product Quality and Safety Surveillance Data Review Board (PQSS DRB) that drive product quality.
- Audited Management review and Purchasing procedures and processes as part of Internal Audit Process lead by Quality Compliance teams.
Staff Operations Process Engineer, Operations Integration
LifeCell Corporation
Bridgewater, NJ
06.2014 - 02.2016
- Strengthened company's business by leading Operations implementation of a Business Development project designed to facilitate autologous adipose tissue transfer for cosmetic and reconstructive surgery by an electromechanical medical device.
- Spearheaded Operations' initiative to create processes for bringing on external manufacturers for complementary products to LifeCell's core manufacturing.
- Created new revenue stream through commercialization of LifeCell's first externally manufacturing adipose processing system, Revolve, which has exceeded budgeted sales by over 200% in 4Q2014.
- Worked directly with vendors and internal customers to initiate cost savings for business in excess of $500,000 through COGS reduction initiatives.
Senior Process Engineer, Operations Integration
LifeCell Corporation
Bridgewater, NJ
09.2010 - 06.2014
- Launched a successful Laparoscopic biologic product in Canada as the Core Team leader for Operations.
- Hired, trained and directly managed junior Process Engineers (levels I and II) in addition to leading 5-8 matrixed engineers as part of multiple global cross functional project core teams.
- Audited and set up third party manufacturers (international and domestic) for new product introductions including establishing the supply chain to ensure uninterrupted product supply.
- Developed, trained and rolled out new technical reviewer policies which standardizes validation document review across the entire organization.
- Trains company on best industry validation practices as well as Certified Tissue Banking Specialist (CTBS) Exam Prep on the human tissue industry as a certified Quality Engineer through ASQ.
Senior Scientist, Product Support and Quality Control
Veridex, LLC, A Johnson & Johnson Co
Raritan, NJ
03.2004 - 09.2010
- Launched GeneSearch Breast Lymph Node Assay diagnostic kit in July 2007 (PMA approved medical device) as Operations core team member.
- Implemented Product Support function for GeneSearch and CellSearch products including processes to investigate and support supply chain (manufacturing/QC) and customer complaint handling.
- Participated in site quality investigations directly with FDA and TUV auditors (ISO) for product recalls, MDR (medical device reporting) and technology transfer of products.
Senior Scientist, Manufacturing
Roche Molecular Systems
Branchburg, NJ
10.1997 - 02.2004
- Partnered with Quality for successful transfer of multimillion-dollar business producing Cystic Fibrosis early predetermination kit (CF Gold) from Roche Applied Systems in Indianapolis to Roche Molecular Systems in Somerville, NJ.
- Supervised nine employees to run two million dollar research products business for two years without any customer backorder.
- Increased reported direct labor accuracy from 40% to 75% by analyzing and correcting master data in SAP/R3, Material Requirement Planning (MRP) software system. This reduced COGS and increased overall profit margin.
Education
MBA - Healthcare Management
Florida Institute of Technology
Melbourne, FL01-2015
Bachelor of Arts - Biology
Rutgers University
Newark, NJ01-1996
Skills
- Strategic planning
- Cross-functional collaboration
- Operations management
- Cross-functional team coordination
- Talent development
Certification
- Class of 2025 STAR 48 (Shaping Talent & Accelerating Results) Graduate, a 9-month Leadership Program and the Class of 2020 Supply Chain Leadership Development (LE2ED) 6-month training program
- Certified Project Management Professional (PMP) through Project Management Institute (PMI) 2021- present
- J&J Six Sigma Greenbelt Certified (2007)
- Certified Quality Engineer (CQE) awarded by American Society For Quality (ASQ) Dec 2013 - present
- J&J Six Sigma Greenbelt Certified (2007)
- Certification in Management Fundamentals, a year-long management training and First Line Leadership through J&J.
- President of Ethi-COM Toastmasters club at Ethicon, Inc and Manager of the WeSustain Raritan Community Garden
Languages
Portuguese
Limited Working
Timeline
Sr. Manager, Quality Engineering
Ethicon
11.2021 - Current
Manager, Product Management
Ethicon
03.2019 - 10.2021
Staff Quality Engineer
Ethicon
02.2016 - 03.2019
Staff Operations Process Engineer, Operations Integration
LifeCell Corporation
06.2014 - 02.2016
Senior Process Engineer, Operations Integration
LifeCell Corporation
09.2010 - 06.2014
Senior Scientist, Product Support and Quality Control
Veridex, LLC, A Johnson & Johnson Co
03.2004 - 09.2010
Senior Scientist, Manufacturing
Roche Molecular Systems
10.1997 - 02.2004
Bachelor of Arts - Biology
Rutgers University
MBA - Healthcare Management
Florida Institute of Technology