Technician Quality
Resume:
JESSE T. HINKEL
***********@*****.***
PROFESSIONAL EXPERIENCE
Intersect ENT, Menlo Park, CA 2011 - 2018
Medical technology company manufacturing drug-delivery ENT devices, best known for developing the first bio-absorbable drug-eluting sinus stent with localized corticosteroid delivery.
Senior Quality Assurance Technician, March 2016 – July 2018
Performed dimensional and visual inspections on incoming parts in accordance with the parts specification, CAD drawing (solidworks), GD&T, cGMP, QSR and ISO (13485) regulations
Generated detailed and accurate inspection and testing reports pertaining to IQA, in-process, final packaging inspection, product lot release, first article inspections (FAI), and verification and validation testing activities, including at off-site facilities.
Initiated and assisted with NCMR reports and investigations
Implemented improvements to controlled documents, including, Forms, SOPs, TMs, MPIs, WIs, and Part Specifications
Extensive experience with Instron, CMMs (OGP smart scope, ROI, RAM, Keyence); Small hand tools: calipers, micrometers, pin gauges; Software including QCBD, AGILE, QAD, NiceLabel, Microsoft Office Suite
Solely responsible for swing shift’s inspection reviews, labeling and releasing of parts.
Initiated, approved, and reviewed lot history records (LHR) / Batch records
Performed Sterile Load processing, testing and review
Interviewed and provided input to hiring managers for all IQA candidates
Trained new employees on GMP, procedures, testing methods, and job responsibilities
Participated in audits with FDA and State Department of Health. Helped explain and answer questions pertaining to Manufacturing / Quality procedures and processes
Conducted a company wide inventory list of tooling (TLCs) from all departments, and created an accurate TLC log
Suggested multiple process improvements that resulted in significant cost savings annually (totaling >$1m)
Quality Assurance Technician 2, March 2015 – March 2016
Quality Assurance Technician, February 2014 – March 2015
Manufacturing Assembler, October 2011 – February 2014
Century 21 Pinnacle, Bethlehem, PA 2006 - 2010
Realtor Closed 36 units
EDUCATION
International Institute of Geometric Dimensioning and Tolerancing (GD&T), Introduction to Dimensional Metrology Certification
Ohlone College, Building Performance Industry Certification
Center for Employment Training, Green Building Construction Certification
Northampton Community College, Real Estate Certification
San Mateo High School - Class of 2004
Contact this candidate