Quality Engineer- Medical Device Manufacturing

TekWissen LLC; Miami (FL); On-site; USD 70,000 - 95,000; Full time

Job summary

A leading technology firm in Florida is looking for a Quality Engineer specializing in medical device manufacturing. This role involves ensuring product compliance with quality standards through audits and inspections, analyzing data for gauge evaluation, and developing corrective action plans. Candidates should have a B.S. in engineering or equivalent certifications, along with at least 3 years of relevant experience. Strong orientation toward results and excellent communication skills are essential for this position.

Qualifications

• Ability to deliver results and meet deadlines.
• Strong communication skills to engage with multiple levels of the company.
• High potential for future development and opportunities.

Responsibilities

• Ensure products meet established standards through audits and inspections.
• Develop corrective and preventative action plans.
• Analyze data for product evaluation.

Skills

Deadline orientation

Oral and written communication

Microsoft Office Suite

Blueprint reading

QSR/ISO regulations

Design assurance

FMEA

Product testing methods

Education

B.S. in engineering or equivalent

Certified Quality Engineer (CQE)

Job description

Quality Engineer- Medical Device Manufacturing

Contract

Responsibilities

• Responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. Interacts with many different functional departments, suppliers.
• Develops and implements corrective/preventative action plans.
• Collects and analyzes data for gauge and product evaluation.
• Identifies critical personnel, gauges, procedures, and materials needed for the completion of new products.
• Ensures that suppliers have necessary information and facilities to deliver quality products

Qualifications

• Ability to deliver, meet deadlines and have results orientation.
• Able to communicate both orally and in written form to multiple levels of the company.
• Demonstrates characteristics of high potential for future development opportunities.
• Microsoft Office Suite
• Basic knowledge of blueprint reading and geometric dimensioning and tolerancing, basic understanding of QSR/ISO regulations, design assurance, FMEA, and product testing methods, and are able to use optical comparators and CMMs.
• B.S. in engineering or an alternative Bachelor’s degree program with certification as a quality engineer (e.g. CQE) plus 3 years experience in a Quality Engineering role, or an equivalent combination of education and experience. Certified Quality Engineer (CQE) preferred.