Summary: Seeking a Quality Engineer with experience in the medical device industry to support ongoing process and equipment validations, drive continuous improvement activities, and manage quality control personnel.

Requirements:

• BS Degree

• 1-2 years of real-world medical device industry experience

• Experience in process validation (IQ, OQ, PQ)

• Experience in equipment validations

Responsibilities:

• Support the Quality Manager for ongoing process validations for product and equipment

• Work closely with operations and engineering to reduce scrap

• Drive continuous improvement activities to reduce customer complaints and lower response time

• Investigate internal and external quality issues and identify root cause, using data analysis, data trending, and periodic reporting

• Perform product and process validations (IQ, OQ, PQ)

• Ensure product and process validations are completed

• Perform discrepant material disposition with guidance

• Recommend inspection plans, test methods, and standard operating procedures

• Conduct sample size determination, statistical analysis, root cause analysis and applicable training

• Contribute to various manufacturing projects such as process development, cost reduction and quality improvement initiatives

• Collect and trend quality indicators for monthly and quarterly reviews

• Support documentation development including writing specifications for manufacturing or scientific test results

• Support in management, implementation, and documentation of IQ, OP, PQ. Participate in cross-functional teams in continuous quality improvement projects. Participate in the Internal Audit process and assist in addressing observations. Determine quality improvement parameters by identifying statistical methods relevant to manufacturing processes.

Pay Details: $30.00 to $35.00 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/
The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.

About the Company:
Entegee

ENTEGEE has over fifty years of experience in providing Fortune 500 and other companies with highly qualified technical personnel. All our offices combined currently employ over 2500 contract engineering and programming specialists, and maintain an internal staff of over 300 successful recruiting and customer service personnel.

Our reputation for quality personnel and responsiveness has established us as a primary supplier to companies throughout the U.S. and abroad. ENTEGEE has an internal engineering staff that greatly increases our technical knowledge and improves the quality of technical personnel we can supply.

To Read our Candidate Privacy Information Statement, which explains how we will use your information, please visit: http://www.entegee.com/candidate-privacy-information-statement/The Company will consider qualified applicants with arrest and conviction records.

Company Size:
100 to 499 employees

Industry:
Staffing/Employment Agencies

Founded:
1958

Website:
http://www.entegee.com/