Continuous Improvement and Data Analytics Manager Global Quality

Tyriina K.O. Kalenberg 320-***-****

Hutchinson, MN *******@*****.***

https://www.linkedin.com/in/tyriina-k-o-kalenberg-56ab1349/ Inspiring a data analytics, people and DBS approach to solving problems Adept at leading and accelerating teams to tackle complex problems by helping them grow and flex their critical thinking and data literacy muscles

Highly professional, articulate Quality leader with 14 years’ experience. Strong analytic, management and coaching skills. Adept at guiding and influencing teams in a matrix organization to meet objectives. Highly adaptable in any business environment. An effective leader with a proven track record of meeting aggressive targets. Ability to communicate at all levels within an organization. Passionate about developing people and implementing improvements through creation of creation, implementation and coaching of streamlined business processes aligned with regulatory requirements, company policy and strategic vision FDA 21 CFR Part 820 ISO 13485, 14971, 9001 IVDR-2017/746 Class III Med Device Auditing Quality Mgmt. Sys.

(QMS) CAPA Post Market Surveillance/Complaints MS Power Platform (BI, Apps, Automate) MS Project MS Visio Business Objects (BOXI) R Minitab JMP Daily Management Problem Solving Process Transactional Process Improvement

Experience

3M; Maplewood, MN 2018 - Present

Continuous Improvement and Data Analytics Manager 2020 - Present Global Quality

• Established and implemented quality data analytics strategy and PBI reports supporting inaugural global QMSR, resulting in >10% multi-YOY improvement of Level 1 Quality KPIs

• Orchestrated multiple cross functional/cross business global kaizens with teams of 6-25; resulting in establishing and improving global quality standards

• Established and directed Global Quality operating rhythm, including creating & approving all C-suite communications on a weekly, monthly and quarterly basis Quality Engineer 2018 - 2020

Clean Coating and Converting Focus Factory; Hutchinson, MN Site

• Developed and implemented strategic quality initiatives for CCC Focus Factory, resulting in improved process performance though use of time studies, standard work, complaint analysis, design of experiments, and test method validation

• Investigated and drove improvement in quality system transactional processes through multiple Lean Six Sigma green belt projects

• Created site-wide Change and Risk Management program, training 10 trainers to distribute program to 700 associates. Site Subject Matter Expert and process owner

• Supported both front and back room audit activities for regulatory, customer and internal audits Tyriina K.O. Kalenberg *******@*****.*** Page 2

Beckman Coulter Diagnostics; Brea, CA 2013 - 2018

Danaher Business System Leader (Continuous Improvement Mgr.) 2017 - 2018 Global Quality; Brea, CA (Remote)

• Created and managed Global Quality group Daily Management (DM) and Kaizen funnel, resulting in prioritized global process improvements

• Directed and facilitated 8 cross functional global process improvement kaizens, including Presidents' and SHIN kaizen events for multiple QMS systems including, Process and Equipment Validation, Complaints, CAPA, Training and QMSR

• Led and coached Problem-Solving Process (PSP) for a team of 10, owning 24 level 1 KPIs Global CAPA Process Owner & CAPA Review Board Manager 2018

• Appointed positions on top of Danaher Business Systems Leader position

• Supervised team of 3 entry level professionals, included training on quality management systems and career development

• Oversaw global CAPA review board of 7 cross functional team members to monitor, review, approve and close global CAPA records

• Owned Global CAPA process, including, CAPA procedures, audits, training, IT system improvements, level 1 KPI performance. Guided problem-solving process when KPI performance was of concern Quality Assurance Scientist I & II, Complaint Handling Unit (CHU) 2015 – 2017 Global Chemistry and Immunoassay Business Unit, Chaska, MN

• Investigated customer feedback for failure cause in FDA/IVDR regulated environment, filing Adverse Event reports as required

• Primary Consumables Investigator, provided data and investigations supporting > 20 product recalls and Supplier Corrective Action Reports

• Danaher Business Systems Practitioner (Continuous Improvement): Led and facilitated multiple cross functional business unit level process improvement kaizens, problem solving processes, and daily management

Senior Technician 2013 – 2015

Reagent Manufacturing, Chaska, MN

• Performed large scale purification of monoclonal and polyclonal antibodies in an FDA regulated environment while performing Design History Record (DHR) review and disposition of product to released status

• Trained in new staff as Qualified Trainer for Purifications Group Education

Master of Science; Quality Assurance; California State University Bachelor of Science; Biochemistry; University of Wisconsin-Madison Tyriina K.O. Kalenberg *******@*****.*** Page 3

Professional Development

ASQ Certified Medical Device Auditor (CMDA) (Exp: 2026) Certification #: 1523 PowerApps – Complete Guide to MS PowerApps; Udemy for Business NOV 2022 Power BI: Dashboard in a Day; New Horizons Computer Learning Center NOV 2021 DBSU: Danaher Daily Management (DM) Certified Trainer MAY 2018 DBSU: Problem Solving Process (PSP) Certified Trainer JAN 2018 DBSU: Transactional Process Improvement (TPI) Certified Practitioner JAN 2018 Training and Facilitation Techniques (TFTI) SEP 2016 Hazard Analysis and Critical Control Point (HACCP); Deibel Labs DEC 2011 Additional Work Experience

Ohly Americas; Hutchinson, MN

Quality Control Microbiologist 2011 - 2013

University of Wisconsin; Madison, WI 2002 - 2009

Laboratory Technician 2008 - 2009

Senior Undergraduate Research Assistant 2002 - 2008 Publications

• The utilization of customer feedback from medical device company perspective Dec 2017; CSUDH

• Quantitative trait loci for biomechanical performance and femoral geometry in an intercross of recombinant congenic mice: restriction of the Bmd7 candidate interval JUL 2009; FASEB J

• Evidence that mechanosensors with distinct biomechanical properties allow for specificity in mechanotransduction. JUL 2009; BIOPHYS J

• The role of phosphoinositide 3-kinase and phosphatidic acid in the regulation of mammalian target of rapamycin following eccentric contractions. JUL 2009; J PHYSIOL.

• Dual energy X ray absorptiometry of ex vivo HcB/Dem mouse long bones: left are denser than right. JAN 2005; CALCIF TISSUE INT.

• Accuracy and precision of PIXImus densitometry for ex vivo mouse long bones: comparison of technique and software version. SEP 2004; J CLINICAL DENSITO

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