Quality Engineer

PROFESSIONAL SUMMARY

I am an innovative, process driven and results oriented Senior Quality Professional. My background includes knowledge and application of cGMP standards, FDA and ISO Audits, vendor auditing, internal audits, product quality, project management as well as extensive experience in chemistry laboratory operations. Have worked as a team leader and an individual contributor. I have a proven ability to facilitate communications between quality and technical groups to facilitate the CAPA process for both process improvement and root cause analysis. I thrive in a fast paced, ever changing regulated work environment.

Extensive experience supporting CAPA investigations including proficient use of investigative tools such as DMAIC problem solving process

PROFESSIONAL EXPERIENCE

STERIS LABORATORIES October 2019 – February 2020

On-site management representative in The Netherlands to facilitate compliance for outstanding regulatory body major audit observations

Management representative for December 2019 ISO audit

Developed and executed Data Integrity Program for the Utrecht, Netherlands facility

Implemented Quality Action Plan

TELEFLEX MEDICAL March 2018 – Jul 2019

Quality Manager

Site quality lead of organization to a ensure compliant product with laboratory, document control, inspection, and process improvement personnel

Management representative for FDA, ISO, and Corporate audits

Developed and promoted team members with creation of Individual Development Plans and quarterly follow ups

Created recognition program to observe anniversaries

Reduced site nonconformances 24 % and complaints 13% while reducing overtime 9%

Implemented site metrics program to monitor quality objectives

Overhauled internal audit program to promote audit readiness

Implemented cross training to optimize team member skill sets and eliminated unnecessary headcount

Held Quality Town Hall presentations to promote quality throughout the site

BAXTER HEALTHCARE January 2015 to March 2018

Quality Engineer

Supported the implementation of a revised complaint trending process that included performing lot-based trending to assess systemic / abnormal complaint reporting associated with individual production lots. The trending performed included review of reported problems by associated Hazardous Situations to determine and assess patient risk and potential impact.

Primary contributor on a program to eliminate a backlog of open CAPA investigations associated with therapeutic solution products complaint triggers. Therapeutic solution product CAPA backlog reduced from 84 open investigations to a total of 2 from Jan-2015 through Jul-2016.

Daily triage of complaint triggers associated with therapeutic solution and disposable device products to determine if escalation into a Nonconformance is warranted. Coordinated evaluation activities between resources including Product Design Owners, Quality Engineering, and production site representatives, to evaluate complaint triggers for potential systemic issues.

ORGAN RECOVERY SYSTEMS, INC. December 2006 to April 2014

Quality Manager

Responsible for company quality activities for all Organ Recovery System products vendor/supplier audits, Corrective and Preventive Actions, complaint investigations, leader in internal and external audits, maintaining compliance and adherence to FDA and ISO regulations.

Lead auditor for performing supplier quality audits, monitoring supplier performance, closing supplier related CAPA’s and complaints, and creating supplier audit schedules. 100 % of all supplier audits completed on time.

Maintained weekly contact with all vendors and suppliers to insure adherence to standards, compliance and productivity. 0% backorders received during three years of tracking.

Provided guidance to suppliers regarding cGMP standards, Quality Production standards and regulations.

Partnered with Operations to qualify, maintain, and approve all vendor and supplier activities.

Created and implemented training program and responsible for the training of all company personnel.

Co-chair for FDA/ISO audits and responses. 100% of all audit responses completed within required time frame.

Led CE mark label requirements project-aligned product labeling to conform to CE standards.

Coordinated relocation of sterilization facility without a gap in production schedule. Implemented standardized formulation between three vendors. Zero backorders received during transition.

Led the EO sterilization re-validation of suppliers which led to the replacing of production components to meet new standardization requirements.

ABBOTT LABORATORIES March 1995 to March 2006

Analytical Quality Assurance (AQA) Chemistry Laboratory Supervisor (March 2000 to March 2006)

Supervised 10 technicians over two shifts utilizing over 100 test methods and a variety of analytical instrumentation.

Mentored technicians to understand and adhere to a continually evolving regulatory environment and optimize their professional development.

Established reward and recognition program for department.

Maintained laboratory environment in accordance with ISO, QSR and FDA regulations.

Created and implemented training program to more efficiently certify new hires. 100% of training completed on time.

Increased testing flexibility through implementation of new scheduling process.

AQA Chemistry Laboratory Coordinator (March 1999 to March 2000)

Coordinated daily activities for analytical laboratory.

Established priority system for testing which positively impacted the efficiency and turnaround of testing in support of the demands from the planning and manufacturing organizations.

Trained satellite facility technicians due to consent decree requirements.

AQA Chemistry Laboratory Technician (March 1995 to March 1999)

Performed Quality testing and auditing of documentation.

Cross-certified in multiple laboratories of department.

Assumed responsibilities to support departmental functions.

EDUCATION

ST. NORBERT COLLEGE

Bachelor of Science, Chemistry; Minor in Biology

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