Quality Assurance Medical Device

Suhail Loatman

Sunset Vista Drive Cell: 863-***-****

Lakeland, FL 33812 Email:************@*******.***

Profile

Summary of Qualifications

Employment History

Result-oriented technician with broad experience from child care and development to medical device processing, products and pharmaceuticals. Proven skill in managing multiple people in high priority tasks. Hands on achiever and fast learning problem solver.

•Strong work ethic and self-motivated

•Detail and results oriented

•Trainer and instructor with outstanding communication skills

•Time management with proven leadership skills

Lidworks, Food Service Lids

11/22/2022- Current

Quality Specialist

Assist Quality Engineer and Engineering department functions as they relate to Quality testing.

Implement quality procedures established to inspect finished goods, including dimensional, functional and aesthetic assessment/analysis. Assist in monitoring facility compliance to GMPs. Assist with statistical analysis/documentation/reporting of production processes related to final product attributes and specifications.

Audit production operations to ensure conformance of product and packaging.

Inspect/validate incoming raw material samples and COAs. Communicate approval to applicable departments.

Accurately and completely record all inspection activities and instances of product nonconformities.

Perform Internal Quality Audits as part of Audit Team to support SQF compliance.

Act as Lead Trainer for new and/or backup Quality Technicians on all shifts.

Assist with internal/external product issue investigations (data recovery, research, sample testing).

Initiate Product/Process Deviations as necessary to support the Production processes.

Support the Quality Assurance Manager in auditing facility for regulatory/certification body compliance.

Assist the Quality Assurance Manager in other Quality functions as directed.

InterActive Cards LLC, Financial Technologies 07/2015-07/2021

Quality Inspector

Supported Research and development projects, manufacturing, and process improvements. Performed numerous ISO standards testing for validations, Dynamic bending, torsion testing, and thermocycling.

•Responsible supporting manufacturing optimization, and process improvements, for a variety of ISO testing.

•Performed Clinical-use integrity testing for validations, and investigations.

•Performed failure analysis leading to validations.

Stryker Sustainability Solutions, Medical Device Reprocess (Formally Known as Ascent Healthcare Solutions)

Advanced Manufacturing Technician, R&D

3/2010-3/2012

Supported projects such as line extensions, manufacturing, and process improvements for a wide variety of surgical instruments in a very fast paced environment. Performed numerous clinical-uses testing for validations and investigations.

•Lead technician responsible for supporting 298 unique products including project launches, manufacturing optimization, line extensions, and solving manufacturing challenges.

•Lead technician in the successful qualification of third party supplier/vendor transfer in order to increase quality of two product lines.

•Lead support in arthroscopic wand product launch to increase revenue by $500K/yr.

•Performed clinical-use and integrity testing for validations and investigations regarding Laparoscopic Scissors, Arthroscopic Shavers, Blades and Biopsy Forceps.

•Provided technical consultation from production perspective to cross functional team.

•Directly supported expansion of Arthroscopic Shaver line to launch Ambulatory Surgical Center maker growth initiative; opening more than $500K in potential revenue.

•Investigated CAPA and customer complaints by performing failure analysis leading to validations.

•Trained managers, supervisors and technicians on testing equipment, approved process design changes and safety compliance in the workplace.

Ascent Healthcare Solutions, Medical Device Reprocess or

Supervisor/Team Lead, Production/Manufacturing 04/07 – 03/10

Supervisor to new product line requiring extensive attention to product quality. Team Leader for multiple and dissimilar product lines.

•Responsible for maintaining production targets.

•Trained and guided operators to properly follow manufacturing procedures and inspect product for critical to quality attributes.

•Managed and scheduled multiple operators to perform manufacturing objectives.

•Coordinated timing of external department requests for operator assistance.

•Maintained logistical needs while assisting supervisors reach production efficiencies.

•Responsible for enhancing teamwork across multiple operators.

Cardinal Health, Medical/Pharmaceutical Products

Quality Assurance Technician, Quality Control 04/02-05/04

As part of Quality Control: Conducted narcotic handling, performed inventory tracking, shipment verifications. Monitored cycle counts and military distributions.

National Head Start, Early Childhood Learning

Teacher’s Assistant 08/01-03/02

Community Outreach, Observations of Children, Curriculum Planning, Hands on Learning and Problem Solving.

Place For Kids Daycare, Child Care

Owner/Operator 07/99-03/02

Observations of Children, Curriculum Development and Implementation, Staff Training, Accounts Payable/Receivable, Problem Solving.

Rite Aid Pharmacy, Pharmacy 08/98-04/99

Dispensing prescription drugs, and other medical devices to patients, administrative duties in pharmaceutical practice, reviewing insurance information.

Education

Glassboro High School 19994

Other Skills and Training

•Fluent in Spanish

•MS Word

•1999: New Jersey Dpt of Human Services Family Day Care Provider

•2000: Child Development Associate Assessment and Competency Standards; Young Infants

•2010 Excel Intermediate

•2012/2014:Materials Characterization

•OSHA 10 Certified (36-702******)

•IATA DGR 60th Edition Class 9 Certified (433F09CE-2D98B-11EA-95C6-0050568D5CA3)

•DOT Shipping Lithium Batteries Certified (A1AF3E03-2B36-11EA-95C6-0050568D5CA3)

•Introdctory Coursework in Health Care

References Available Upon Request

Contact this candidate