Compliance Specialist/Quality Control Resume Example Medtronic Covidien, Ponce, P.R

COMPLIANCE SPECIALIST/QUALITY CONTROL

Profile

Responsible and committed professional seeking a job opportunity within the quality assurance department of an Engineering- related company to expand knowledge base and contribute to success at the workplace.

Skills

GD&T
Knowledge of Root Cause Analysis and CAPA
Basic knowledge of QSR,ISO,GMP and SOP
Experience with high precision measurement instruments (C.M.M, micrometers, digital calipers, optical comparators, electronic microscopes, Mohawk, indicators, radius gauges and high gauges)
Windows Operating System with Office Suite® (Word, Excel, Publisher, Access, Outlook, and Power Point)

Professional Experience

Compliance Specialist/Quality Control
September 2014 to February 2015Medtronic-Covidien, Ponce, P.R

Responsible for the revision and retention of quality system documents such as validation, deviation records, protocols, authorized signatures logs, NCR's and sampling plans.
Handle procedures, work instructions, forms and layouts for electronic revision update.
Complete typing and proofreading of procedures and engineering documents.
Manage internal procedure processing through the Change Management System (CMS) workflow in Agile software®, including its revision, approval, tracking and issuance.
Assist with change control process of all change orders within the electronic quality system.
Handle electronic approval of all change orders (procedures, drawings and specifications) to assigned personnel within the manufacturing and engineering departments.
Electronically implement standard operating procedures (SOP) and modify work instructions used in production of all shifts.
Ensure procedure: (SOP), ECO, DR, NCR and drawings compliance to regulations.
Complete required documents for engineering projects in addition to general filing and copying.

Quality Control Technician
May 2014 to September 2014Covidien USSC | Ponce, P.R

Perform inspection and verification of incoming material.
Verify compliance with product specifications and quality requirements.
Make use of various high precision measurement instruments to perform dimensional and visual inspections of incoming products.
Read and interpret blueprints.
Apply math knowledge to analyze and solve measurement issues.
Enter inspection results in a computer database.
Help with inventory control and material movement.
Identify non-conforming products and communicate inspection results to the quality assurance management for evaluation.
Comply with the company quality policies and procedures.

P.R. Inspector Packer
March 2014 to May 2014Classic Industries/ CTS

Perform quality control inspections of injection molded products.
Mostly work in the manufacturing area.
Perform inspection, cleaning, monitoring, assembly and packaging of injection molded medical products.

Quality Control Assurance Inspector
May 2013 to February 2014Zimmer Manufacturing BV/ CTS |Ponce, P.R

Perform quality control inspections, measurement and testing of incoming products.
Apply standard concepts, good manufacturing practices and procedures related to quality control in a regulated industry.
Use of micrometers, calipers, optical comparators, high gauges, sampling plan tables, go/ no go gauge, indicators and other measurement equipment.
Efficient reading blueprints and applies math knowledge to analyze and solve measurement issues.
Constantly communicates with manufacturing staff of all levels in English and Spanish.
Data entry using computer programs such as: MS Office, Word, Power Point, and Excel ®Work different shifts and assist managers with troubleshooting.

Education and Training

and Hato Rey, PR) Bio- Environmental/ Biological EngineeringCombined Program of NCAT State University and Polytechnic University of Puerto Rico － Greensboro, NC

B.S : 2016NCA&T － Greensboro, NC, 27409GPA: GPA: 3.53

GPA: 3.53

OSHA (30 hrs. Environmental Health and Occupational Safety), RCRA, Renewable Energy and Technology, Quality Assurance Inspector ( FDA Regulated Industry), Validation Specialist

Affiliations

ASABE

SHPE

Alpha Epsilon Honor Society

Languages

English/ Spanish

Additional Information

Skills

Agile software, Basic, blueprints, C, calipers, Change Management, CMS, copying, data analysis and acquisition, Data entry, database, engineering projects, English, Environmental Health, filing, forms, GMP, inspection, Inspector, inventory control, ISO, math, micrometers, Access, Excel, MS Office, Office, Windows Operating System, Outlook, Power Point, Publisher, Word, Occupational Safety, packaging, personnel, policies, Presentations, PR, Problem Solving, progress, proofreading, protocols, quality, quality assurance, quality control, Fast Learner, reading, Read, SOP, Spanish, Supervision, tables, troubleshooting, typing, Validation, workflow.

Resume Overview

Companies Worked For:

Medtronic-Covidien, Ponce, P.R
Covidien USSC | Ponce, P.R
Classic Industries/ CTS
Zimmer Manufacturing BV/ CTS |Ponce, P.R

School Attended

Combined Program of NCAT State University and Polytechnic University of Puerto Rico
NCA&T

Job Titles Held:

Compliance Specialist/Quality Control
Quality Control Technician
P.R. Inspector Packer
Quality Control Assurance Inspector

Degrees

and Hato Rey, PR) Bio- Environmental/ Biological Engineering
B.S : 2016
OSHA (30 hrs. Environmental Health and Occupational Safety), RCRA, Renewable Energy and Technology, Quality Assurance Inspector ( FDA Regulated Industry), Validation Specialist

Compliance Specialist/Quality Control Resume Example

Resume Score: 90%

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