Supplier Quality Assurance Engineer - Fort Lauderdale, United States - Trividia Health

Trividia Health Fort Lauderdale, United States

3 weeks ago

Description

*Please note this position is Monday - Friday onsite located in Ft. Lauderdale, FL

SUMMARY

Individual is responsible for the investigation, analysis and the resolution of supplier quality problems by conducting audits, analyzing defect trends and participating in continuous improvement projects.

Ensuring Quality System requirements are met, and support of new product and sustaining engineering efforts through the selection and approval of new and existing suppliers.

These responsibilities include participating with cross-functional team members (R/D, Manufacturing, Process Development and Supply Chain) to understand product requirements (inputs, outputs, verification/validation testing) to ensure that the raw materials delivered to THI meet the overall quality requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES
include the following. Other duties may be assigned.

Work with Supply Chain to ensure supplier performance is regularly reported and that appropriate and timely corrective actions are implemented.

Maintain and update critical supplier audit system and schedule.

Conduct Internal Audits per FDA, cGMP and ISO 13485 requirementsPerform Suppliers Quality Audits for Domestic and International suppliers per FDA, cGMP and ISO 13485 requirements.

Establish specific short/long term supplier quality goals.

Aide R&D and Manufacturing in the evaluation and qualification of new supplier materials following a defined new product development process.

Provide educational and knowledge opportunities directed at establishing, developing, expanding supplier capabilities.
Take a leadership role in completing, tracking, and maintaining SCR's, SCAR's and Material NCEN's.
Develop new and/or revise Material Specifications and procedures to include incoming inspection and test on raw materials upon receipt.

Strategically lead supplier performance improvement projects in an effort to increase the supplier capability of consistently meeting Trividia Health's requirements.

Projects may include process analysis, process capability and throughput analysis 6-Sigma and value stream mapping and drive "Zero Defect" mentality within the supply base.

Champion problem solving and root cause analysis activities with suppliers and customers to eliminate recurrence of non-conformances.
Champion the use of Statistics and Statistical analysis to drive change and improvement.
Must be able to work with minimal supervision, balance multiple projects & prioritize work.

SUPERVISORY RESPONSIBILITIESThis job has no direct supervisory responsibilities but may be called upon to take lead responsibility for tasks/teams related to projects involved with.

Interview and train subordinates/new employees in all aspects of department Quality related activities per ISO and FDA guidelines

QUALIFICATIONS and/or EXPERIENCE

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily and be able to work with minimum/no supervision.

Bachelor's Degree in Engineering or Science field with 5+ years of experience in medical device Supplier Quality Engineering or a related discipline OR Master's Degree in Engineering or Science field with 3+ years of experience in medical device Supplier Quality Engineering or a related discipline is preferredMust have experience and knowledge of CMDCAS, ISO 13485, ISO 14971 and 21 CFRKnowledge of statistics and statistical analysis a plus.

CERTIFICATES, LICENSES,

REGISTRATIONS:
Proficient in Microsoft office (Word, Excel and Power point)ASQ Certification as a Quality Engineer/Quality Auditor is a plusSix Sigma Green/Black Belt is a plus

LANGUAGE SKILLSAbility to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Ability to write reports, business correspondence, and procedure manuals.
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public

MATHEMATICAL SKILLSAbility to comprehend and apply principles of advanced calculus, modern algebra, and advanced statistical theory.
Ability to work with concepts such as limits, rings, quadratic and differential equations, and proofs of theorems

REASONING ABILITYAbility to define problems, collect data, establish facts, and draw valid conclusions.

Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

P

H

YSICA

L DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand, walk, and sit. The employee is frequently required to talk or hear. The employee must occasionally lift and/or move up to 25 pounds. Some (20%) work related travel (car or plane) will be required, both domestic and internationally

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

EQUAL OPPORTUNITY EMPLOYER:
Trividia Health, Inc. is an Equal Opportunity, Affirmative Action, E-Verify employer.

Employment decisions for all applicants and employees will be made without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, age, national origin, marital status, veteran status, disability, or other characteristics protected under local, state or federal law.

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Supplier Quality Assurance Engineer - Fort Lauderdale, United States - Trividia Health

Description

Quality Assurance Engineering Lead