Summary:

Accomplished professional with over ** years of working, training, and leadership experience within Biological, Biotechnological, Chemical, Medical Device, Pharmaceutical, and business sectors. Ensure strict compliance with quality system regulations 21 CFR 820, ISO 13485 / 9001, current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP), Food and Drug Administration (FDA), OSHA, and the Centers for Disease Control (CDC). Adept at composing detailed quality and regulatory audit documents to include: operator and equipment qualification analysis reports, deviation records, monthly key performance indicator (KPI) spreadsheets, monthly quality report responses matrix, internal and external audit defenses, and corrective and preventative action plans (CAPA’s). Designed and created comprehensive training methods, standard operating procedures (SOPs), equipment and program qualifications, verifications, validations, and calibrations (i.e., Installation Qualification (IQs), Operational Qualification (OQs), and Performance Qualifications (PQs). Ample training experience demonstrated by the ability to effectively train staff and strategically develops, implement, and manage processes that adhere to best practices and minimize ambiguity. Proficient in working collaboratively under a Quality Management System (QMS) as part of a cross-functional team that includes development, verification/validation, manufacturing, regulatory, compliance, and quality experts. Well-versed in maintaining three (3) inspection labs with testing equipment, test method validations, calibrations, and PMs. Supported plant cost reduction and process improvement projects using various quality tools such as FMEA, process capability, Gauge R&R, Chart analysis, etc. Hands-on experience in supporting quality engineers in developing test methods and device investigations, calibration activities with the maintenance of tool files and calibration records, and other related tasks determined by QE.

Skills:

Strong interpersonal and communication skills, ability to work effectively with various constituencies in a diverse community.

Excellent attention to detail and organization, and capable of working independently with minimal supervision from a manager.

Knowledge in the use of engineering metrology equipment like OGP, KEYENCE, INSTRON, LLOYD instruments, and CMM

Education:

Associate in Arts (AAPSY), Industrial-Organizational Psychology, University of Phoenix, Phoenix, AZ

Bachelor of Science in Industrial-Organizational Psychology (Expected 2024).

Experience:

Quality Assurance and Training Supervisor 08/2018 – 05/2023

Insulet Corporation, Acton, MA

Quality Assurance Functions:

Managed 15 direct reports across 2 labs and Reworked lab.

Developed an inclusive coaching model to comprehensively improve associate performance and proactively course correct observed behaviors.

Established metrics for Quality Analysts that were base on productivity and quality of evaluations.

Provided leadership to team members, including but not limited to training support on processes and procedures—reviewed applicable DHR documentation, including inspection records, non-conformances, and deviations.

Practical, supervisory, and managerial experience in supplier/IQA, In-process, and lot qualification: inspections, data collection, analysis, and documentation; and participating in external and internal supplier audits.

Supervising the quality team in assisting with engineering processes such as ETR, PCOA, Deviations, RCA, and investigations in support of operations and production.

Involved in initiating and completing IQ, OQ, and PQ verification and validation processes of four (4) production lines.

Assisted in CAPA evaluation and closure for lot mix-ups.

Worked with continuous improvement engineering to develop and set up test methods for reclaiming sub-assemblies components.

ACCOMPLISHMENTS: Worked with Manufacturing Quality Engineering to develop and implement the in-house Heat-Soak process for the pre-sterilized lot qualification lab, completed more than 95% of the work on the standard operating procedures (SOP’s) and forms.

Facilitated calibration sessions with third party monitoring vendor and senior management team.

Training Functions:

Traveled and succeed worked with Automation Engineering and Manufacturing Engineering to develop and qualify new Automated Assembly processes for complicated tight tolerance electro-mechanical sub-assemblies and assemblies.

Set up and validated inspection processes and test methods in manufacturing and laboratories.

Created deviation samples of components and sub-assemblies for training and development of inspection personnel.

Designed and approved qualified test methods of electro-mechanical sub-assemblies.

Worked with Automation Engineering to develop, test, and qualify, validate inline automated inspection stations on automated assembly cells to improve performance levels and meet objectives.

Set up test methods used at Automation equipment vendors. Methods used to accept automation equipment.

Integrated a blended training model that allowed associated sufficient knowledge for success.

Developed a refresher training program that leveraged gap analysis discovered through lead capturing and quality data to improve performance.

Implemented metrics for facilitators and developers that provided consistent feedback and development goals.

Commissioned, scheduled, and designed training that allowed for 300+ associated 3 different shifts to be 100% cross-functional.

Provided supervision, training, and coaching to new hires for a one-two week period, identifying areas of opportunities and determining if new hires will be a right fit for the organization based on their QA evaluation closure percentage and other metrics, provided coaching and training to existing QA techs when key performance indicators are below center standards.

Involved and supported Two (2) FDA inspections and auditing and assisted internal or external auditors in compliance reviews.

Established Manufacturing QA trainer as a key pillar of the organization - trained 400+ employee new hires, an in-house team, and a significant cross-functional department to help drive training effectiveness.

Maintained and reviewed Quality records supporting the Quality System, e.g., training, internal audits, NCR, CAPA, and ad hoc review of manufacturing documentation, ensured Good documentation Practices (GDP), Medical Devices manufacturing, and cGMP regulated industry were followed.

ACCOMPLISHMENTS: surpassed, directed, mentored, and trained the first phase of employees 60+ Manufacturing Quality Assurance techs to support 24/5 operations in under 11 months. Effectively transitioned department to 24/6 operations.

Extensive decision-making experience in In-Process, Outgoing Inspection for components, sub-assemblies, and finished products - for the Manufacturing Process, 21 CFR 820 quality management systems, CAPA (corrective and preventative action) personnel and conflict resolution, and market health hazard assessments and process validations.

Mobilized and maintained the validated twelve (12) fully automated and state-of-the-art custom production cells, including nearly three hundred (300) transformation stations and thirty (30) vision systems in under six (6) months.

Maintained training of the requirements in compliance with FDA and other regulations; ensured training programs updated as needed also fell under the purview of the provisions; prepared accurate, legible, complete records, and adherence to QMS procedures & work instructions.

Formulate or implement regulatory affairs policies and procedures to maintain or enhance regulatory compliance.

Verify that all regulatory policies and procedures have been documented, implemented, and communicated with domestic and international regulations and standards.

Supported and performed internal compliance, “focus” audits throughout the manufacturing plant to evaluated compliance with quality procedures and regulatory requirements, addressed audit findings with personnel, provided guidance regarding proper documentation, and prepared and support submitted audit reports to executive management upon audit completion.

Quality Control Inspector 12/2016 – 08/2018

Insulet Corporation, Acton, MA

Performed functional testing of Lot Qualification devices and ensured testing prioritization to expedite product release and train the new employees.

Supported Quality Engineers in developing test methods and device investigations, calibration activities with the maintenance of tool files and calibration records, and other related tasks determined by QE

Quality Assurance Tech 08/2015 – 07/2018

Vention Medical, Salem, NH

Managed batch and lot releases, audits, regulatory agency inspections, and product recalls.

Conducted periodic internal reviews or audits to ensure that compliance procedures were followed.

Managed and supported the Internal Audit program to affect readiness for rigorous customer and registration audits.

Ensuring systemic integrity by leading the Document Control program and participating in managing process change, corrective action, deviation, and change orders.

Performed Incoming, In-Process, and Final inspections of raw materials and nonconforming products/materials to ensure products met the company standard by 0% finding in reject per quarterly timeframe and trained all new hires.

Quality Control Inspector I 07/2013 – 08/2015

Zoll Medical, Chelmsford, MA

Performed Incoming, In-Process, and Final inspection of procured raw materials, sub-assemblies, and finished good products using an electrical test to verify conformance, utilized Manufacturing Enterprise System (MES), hand tools, micrometers, Defib/Pacer Analyzers X custom fixtures, oscilloscopes, power supplies, and DMMs.

Performed other duties as required, along with training all new hires employees.

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