JAK
A Boutique Consulting Experience
Leader of quality system implementation, integration & remediation. I turn around, strengthen & improve multinational quality systems in order to meet complex stakeholder & regulatory requirements, while optimizing business value & profitability. I am recognized for my natural ability to mobilize multidisciplinary teams & my decisive, solution-oriented approach to address highly dynamic & challenging business needs. An empirical thinker with advanced skills in conducting research, executing process improvements & communicating results.
CONSULTANT HIGHLIGHT
Jesse Kryger
Wright Medical | Mar 2019 - Present (8 Mos)
GLOBAL QUALITY ENGINEER - MANUFACTURING TRANSFER
Core team member of the 'Procurement Excellence Transformation' initiative for lower extremity medical devices; a project working towards $20 m in supply chain savings. Assisting in the implementation & improvement of supplier material qualification processes, while leading quality assessments for manufacturing transfers to improve Corp. profitability & ensure post-transfer effectiveness.
Philips Healthcare | Sep 2017 - Apr 2019 (1 yr 8 mos)
SUPPLIER QUALITY ENGINEER - QUALITY SYSTEM REMEDIATION
Advised leadership through remediation of supplier control processes under an FDA issued consent decree; including the identification, root cause analysis and corrective action of major quality system elements.
Zimmer Biomet | Oct 2016 - Sep 2017 (1 yr)
SR. CAPA ENGINEER - QUALITY SYSTEM REMEDIATION
Facilitated the company's response to FDA citations (483). Investigated, remediated and integrated (merger) major quality system elements including areas in sterilization, software and process validations and management and manufacturing controls.
Philips Healthcare | Apr 2016 - Nov 2016 (8 Mos)
SUPPLIER QUALITY ENGINEER - DESIGN TRANSFER
Remediated elements of the QMS at the Diagnostic CT and Advanced Molecular Imaging division. Led the Production Part Approval Process (PPAP) component of the Advanced Product Quality Planning (APQP) process; including the design verification, validation (IQ/OQ/PQ) and transfer of a new digital X-Ray CT/PET scanner to an offshore manufacturing site in Haifa, Israel. Managed projects between cross functional groups to ensure coordinated engineering changes, purchased parts and supplier qualifications
Haemonetics | Apr 2014 - Apr 2016 (2 yrs 1 mo)
SR. QUALITY SYSTEMS ENGINEER, HAEMONETICS
Directly responsible for quality inspectors overseeing the evaluation of Device History Records (DHR), environmental monitoring, and product acceptance activities. Facilitated the success of the site's first FDA audit; resulted in zero observations (no 483). Improved CAPA and audit finding response time from >1 year to <45 days, with suspended repeat issues. Led the integration of site and corporate QMS. Wrote technical procedures and facilitated document control. Implemented the site-internal audit program and trained internal auditors, led management reviews and participated in international cross-team audits. Participated as lead quality engineer for the implementation of newly automated processes, including process and test method validations for automated assembly processes and vision systems.
Stryker | Dec 2012 - Mar 2014 (1 yr 6 mos)
SUPPLIER QUALITY ENGINEER - ACQUISITION
Led supplier and product evaluation, qualification and approval activities. Performed supplier and product qualifications, including 50+ on-site national and international quality system audits on suppliers to the medical device industry; including EO and gamma sterilization, laboratory testing (investigation and developmental in-vitro), resin, catheter, stents, pouch/packaging, plastic components, calibration, tool manufactures, chemical, validation services, contract manufacturers and device manufacturers (OEM) for Stryker's acquisition of Boston Scientific's Neurovascular products division.
RECOMMENDATIONS
"Jak was successful at working closely with our suppliers to remediate products and documentation to bring the project back on schedule. Jak acted as the SME to execute production verification activities including first articles, process validations and risk assessments"
Mado Otzri, Philips Healthcare
"Jak turned a process that was performing very poorly into one of the top performing QMS processes related to manufacturing. Whereas the inventory value of this process constraint once approached 8 figures, Jak reduced this to less than 10k over the course of 18 months"
David Lockridge, GE Healthcare
"Jak did an excellent job as a CAPA coordinator managing significant remediation activities at ZB. Jak also coauthored several responses and updates to FDA. Jak has a keen understanding of Quality systems, compliance, GMP, and CAPAs"
Larry Thompson, Zimmer Biomet
"Jak built solid working relationships with our international team which helped them to gravitate towards a global quality foot print. Jak facilitated numerous PFMEA and Control Plan creation sessions and led or participated in ten Internal audits. The projects completed were of significantly high quality"
Myron Cheesebourough, Boart Longyear
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