Reema Patel
Lowell
Summary
Highly skilled Quality Assurance Inspector Supervisor with varied experience testing, inspecting products with During inspection and Final inspection to release product, Reviewing Document and release final prod in a large production facility. Exceptional ability to read, interpret and understand engineering documents, blueprints and specifications. Employs sound testing methodology to ensure products are not packaged if they fail to meet standards.
Overview
14
14
years of professional experience
Work History
Supervisor, Quality Control
Lemaitre Vascular
Burlington, MA
11.2022 - 09.2025
- Supervise the collection of data required for QC or plant audits and catalogs or prepares data for use by Auditors and Management.
- Analyzes data to provide requested information to those seeking to verify or confirm results. Works closely with all Managers and Supervisors on any documentation issues.
- Coordinate activities to meet the audit schedules and needs.
- Assists in the supervision and development of QC technicians to achieve maximum performance and technical capabilities.
- Works with QC manager or leads in any Internal and External Audits and assist in the direction of the audit team to ensure compliance for NWF to ensure a successful audit completion.
- Reviews data from employees to validate testing, troubleshooting, lab testing and floor verifications, ensuring that data is accurately and completely recorded.
- Works closely with R&D, QC management and others to certify documentation/records meet standards.
- Makes sure data is recorded/maintained and prepare forms, records, and logs as needed. Maintain such as required.
- Perform other duties and special projects as needed.
Quality Assurance
CURIA (Formally AMRI)
Burlington, MA
06.2017 - 11.2022
- Represent Curia (AMRI) Quality Assurance when managing issues that require immediate corrective action.
- Ensure such action taken is appropriate and appropriately documented.
- Reviews UN-executed/Executed batch records and quality control testing for compliance with internal SOPs and specifications
- Monitor Operations personnel for adherence to SOP’s. Report back to Manager of QA as well as area functional management as to personnel performance, highlighting those areas and individuals in need of improvement
- Reviews and approves Document Change Notifications for SOPs, test methods, raw material specifications, protocols (stability, validation, etc.) and batch records
- Reviews and approves SOPs, test methods, raw material specifications, protocols and executed validation documentation, Authors or revises SOPs
- Performs manufacturing area and labeling clearances as well as inspection of material
- Reviews and approves CAPAs, Deviations, Change Controls, Equipment Excursion Reports
- Assists in performing investigations
- Performs internal audits and weekly walkthroughs.
- External audits for Supplier qualification, with supervision, may respond or manage responses to clients regarding manufacturing and/or documentation issues.
- Assists in developing and delivering training, assists tracking and follow-up on Deviations, Change Controls, Investigations, and CAPAs Develops and/or maintains Quality System metrics for Management Review.
- Provides on the floor support to manufacturing operations
- Perform QA visual inspection activities associated with clinical and commercial drug product.
Quality Control Inspector
Crane Currency
Nashua, NH
06.2015 - 02.2017
- Directly involved in fabricating prototypes for customers and production pieces for manufacturing.
- Used Standards and Tolerances in determining quality of prototype and production pieces.
- Worked with optical comparators at Crane Currency to check for color, laser length of product.
- Used OGP, gage meters for different types of testing.
- Handled upkeep and maintenance of multiple laboratories as well as certain equipment. Ensured work areas and equipment are maintained in a clean and orderly fashion and follows prescribed safety regulations.
- Performed quality control testing and material approval.
- Performed wet processing using solvents, acids, and bases.
- Used ovens and large vacuum deposition systems for processing of technology.
- Implemented process controls for repeatable results.
- Tracked inventory of chemical components and orders materials that were required in all laboratories as well as materials used in the quality control of company products.
- Kept a detailed record of all materials and mixtures shipped and received by the lab department.
- Completed all required ping paperwork for each work order and maintained processing log.
Quality Control
Teleflex Inc.
Chelmsford, MA
09.2012 - 07.2014
- Maintained a complaint and operable Complaint Management Department for the Cardiac product line.
- Promoted processes and procedures that were compliant with the Quality System 21 CFR Part 820 with regards to Complaint Handling.
- Provided guidance to personnel regarding communication tools to the organization, including Sales, Manufacturing, Development as well as sister facilities and suppliers regarding quality.
- Used a foundation of risk based analysis and statistical tools to guide decision-making activities.
- Managed and participated in Complaint Management Meetings for Cardiac Care.
- Responded to FDA and Competent Authorities when requested for additional information as it related to reported complaints.
- Developed and administered the complaint metrics for the Everett Facility.
- Promoted continual improvement of personnel in Complaint Management area which included the Investigation Lab.
- Conducted meetings as required to assess problems with regards to complaint handling.
- Maintained Complaint Management data and files.
- Provided groups, supervisor or other management personnel with Complaint trends data in order to keep them informed of activities and results.
- Established, followed, and improved corporate, department and other applicable company procedures.
- Maintained a cooperative and motivational attitude with co-workers.
- Adhered to and ensured the compliance of Teleflex’s Code of Ethics, all Company policies, rules, procedures, and housekeeping standards.
Quality Control
Light Lab Imaging Inc.
Westford, MA
09.2011 - 08.2012
- Worked with C7 Dragonfly imaging catheters inspection.
- Worked from beginning and ending of the process through assembly inspection.
- Testing device for leak test.
- 100% Final Inspection.
- Reflow coil. Silicone device
- Incoming and outgoing material inspection, Worked under Microscopes more than 8 hours.
Education
AA degree - Bio-Tech
High School Diploma - undefined
Medical Assistant - undefined
SSG Hospital
07-2007
Skills
- Organized focused Quality Assurance Inspector with excellent attention to detail
- Strong ability to read understand and interpret product specifications and engineering blueprints
- Supervises and monitors production floor to ensure products meet specifications
- Applies safety standards to make certain products do not pose hazards to the public
- Collaborates well with management
Timeline
Supervisor, Quality Control
Lemaitre Vascular
11.2022 - 09.2025
Quality Assurance
CURIA (Formally AMRI)
06.2017 - 11.2022
Quality Control Inspector
Crane Currency
06.2015 - 02.2017
Quality Control
Teleflex Inc.
09.2012 - 07.2014
Quality Control
Light Lab Imaging Inc.
09.2011 - 08.2012
High School Diploma - undefined
Medical Assistant - undefined
SSG Hospital