Quality Engineer Medical Device

Professional Summary:

Accomplished, detail-oriented, strategic thinker who is committed to quality with 9 years experience in medical device, pharmaceutical and electronic industries.

Qualifications:

ASQ Certified Quality Auditor

Engaged and Managed Quality Inspectors to Achieve Success

Improved Supply Chain Quality through On-Site Audits

Merged New Division within QMS

Proficient with ISO 9001, 13485, cGMP and FDA Standards

Achieved 5S Auditor Certification for Lean Manufacturing

Managed an Internal Quality Audit Program Achieving a 100% Ontime Response

Created Cross Training Program to Support Staffing Fluctuations

Managed and Assisted with ISO and FDA Audits.

Preformed Gap Analysis on QMS for MDSAP

Utilized FMEA and Process Mapping

Managed Equipment Calibration Program

Kaizen Event Leader and Facilitator

Professional Experience:

Sr. Quality Engineer, Handicare USA, St. Louis, MO Nov. 2018-Apr. 2020

Coordinated with department managers for timely correction of internal audit nonconformances. Achieved a 100% on-time delivery of corrections in 2019.

Revised Internal Audit process to assure audit readiness and assisted in the ISO 13485:2016 audit which resulted in zero findings. This was a first for Handicare.

Reviewed all customer complaints for reportability, and where appropriate filed MDRs and MDPRs. Exceeded quality objective with 100% on-time filings.

Performed gap analysis on quality procedures to assure regulation compliance and created a process to have QOPs reviewed every two years by the owner.

Developed QOP training which enabled the trainee to have a smooth transition utilizing new processes.

Responsible for analysis of customer complaint data. Informed management of trends, effectiveness of design changes, and to aid in the VOC initiative.

Coordinated and assisted with Engineering to perform on-time complaint investigations. As team leader we exceeded our quality objective with 100% on-time investigations in 2019 and Q1 of 2020.

Analyzed data and developed presentations for bi-annual MRM.

Created on-site training for international supplier on final product inspection resulting in a successful FAI.

Managed a pilot program to streamline the receiving and final inspection process, resulting in time saved in receiving and a streamlined approval process in quality.

Quality Engineer, AG Industries, Filtration Group, St. Louis, MO Apr. 17-Nov. 2018

Responsible for daily analysis of scrap and guiding the team to corrective actions to eliminate scrap cost.

Developed and maintained supplier score cards to evaluate suppliers’ performance based on quality of product, response time and on-time delivery.

Negotiated with overseas supplier for reimbursement of sorting and part costs for nonconforming product. Developed SOP with supplier to eliminate shipping damage.

Generated monthly quality reports to inform upper management on the numbers/trends within the customer complaint system, NCR reports, scrap reports, supplier performance, and the cost of quality.

Conducted monthly quality meetings to all employees over 3 shifts to discuss cost of quality, performance on each line and corrective actions made to reduce scrap. This empowered the employees and created ownership.

Quality Assurance Supply Chain Supervisor, Thermo Fisher Scientific, Biopharmaceutical Division, Fisher Clinical SVS, Allentown PA Mar. 2014-Nov. 2016

Managed 10 to 18 QA inspectors within 3 facilities over 3 shifts.

Developed and provided cross-training which supported staffing fluctuations.

Developed and managed productivity and volume metrics for employee scheduling and as a tool for senior management.

Increased RFT rate to 99% by developing and training employees on an internal error reduction program. Created monthly metrics for senior management.

Increased the efficiency of incoming inspection by establishing an electronic priority list for project managers and inspectors.

Participated in a global initiative to develop comprehensive SOPs for receiving comparator drug products.

Reduced OT by 30% through the development of staggered employee schedules.

Utilized root cause analysis and created corrective and preventative actions in response to deviations, customer complaints and audit findings.

Participated on a PPI team that reduced deviations by 50% within distribution.

Utilized FMEA to analyze the process of temperature monitoring.

Quality Assurance Supervisor, R&D Altanova, (formally R&D Circuits), Allentown, PA Mar. 2011-Aug. 2013

Directly supervised 3 quality inspectors.

Managed and integrated a new division into the existing ISO 9001-2008 quality management system. Worked with management team, development engineers and technicians to document SOPs and acceptance standards.

Collaborated with local engineers and the supplier’s engineers to solve material problems causing low manufacturing yields. Experiments, data collection and analysis were completed and documented within the QMS.

Managed the calibration and maintenance system for all tools and equipment.

Developed process control procedures along with training on handling ESD sensitive components and boards.

Utilized control charts, Pareto charts, performance matrix and histograms to inform management and staff which created ownership for quality performance targets.

Created and presented the semi-annual MRM to upper management.

Education:

B.S. Business Administration - University of Missouri at St. Louis

Certifications:

ASQ Certified Quality Auditor - Date Issued: 4/15/2019 - Cert. # 70032

Professional Memberships

American Society for Quality (ASQ)

St. Louis Chapter Leadership Committee - Secretary - 2020

Contact this candidate