What are the responsibilities and job description for the Quality Engineer position at Entegee?
Summary: Seeking Quality Engineers with experience in the Medical Device industry and knowledge of Design Controls, Production, and Sustaining Engineering.
Requirements:
Bachelor's degree in Engineering, Science or other technical degree.
1-3 years of experience with Medical Device or Combination Products Design Controls, Production, Sustaining Engineering, or Quality role.
Proven knowledge and experience in Device Design Control, Risk Management, Medical Devices, and Combination Products.
Experience analyzing patient/user impact.
Understanding and practical knowledge of 21 CFR Part 820, ISO 13485 and ISO 14971 and relevant industry standards.
Working knowledge of statistical methods for data analysis.
Familiarity with microcontroller-based firmware, software verification (unit, static, dynamic analysis).
Familiarity with circuit design, analysis, troubleshooting, and testing; PCB/PCA assembly and fabrication.
Responsibilities:
Complete product and manufacturing process changes including documentation and risk file updates to ensure there is no adverse impact to the patient/user and product design integrity is maintained.
Implement change projects according to internal procedures; supervise progress; communicate status to group leadership.
Establish experimental protocols; conduct experiments; analyze results.
Establish/review specifications/requirements for components/products/processes.
Ensure product conforms to current relevant international standards.
Preferred Skills:
Experience in the medical device industry in a regulated work environment.
Experience with Medical Device Design Controls.
Root cause analysis experience.
Additional Requirements:
-Must be vaccinated.
Pay: 31-42
Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.
Pay Details: $31.00 to $42.00 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/
