Quality Engineer
Quality Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Overview:
- Manages all quality aspects within assigned projects such as: compliance with applicable norms and regulatory requirements risk management design verification validation design history file design change control CAPAs and design transfer
- Develops and utilizes quality tools within the Chicago Innovation Center
- Supports the development and implementation and improvement of the Quality Management System (QMS)
- Work within defined procedures for development including quality environmental health and safety requirements confidentiality and good manufacturing practices
Responsibilities:
- Supports and challenges project team on all aspects of quality
- Approves relevant project documentation per approved development procedure checklists
- Participates in project risk management activities ensuring that tools such as the Risk Management Plan Risk Management Report and FMEA are properly used (product and process derisking).
- Follows up and reports project status regularly to the Unit Quality Manager
- Participates in internal audits
- Actively participates in the QMS maintenance and improvement
- Participates in the creation of and ensures completion of design control documentation for product development programs
- Ensures quality of program documentation including traceability
- Ensures quality of the developed products
Qualifications :
Requirements:
- Bachelors or Masters degree in Engineering Science or related field
- 3 years of experience working in quality departments for the regulated industries of pharmaceutical or medical device
- Working knowledge of relevant regulations and industry standards (FDA 21 CFR 820 ISO 13485 etc.)
- Experience working on design control and risk management documentation for medical devices/combination devices/pharmaceuticals
- Familiar with basic statistics Gage R&R Design of Experiments
- Selfmotivated with good communication skills
- Excellent interpersonal and organization skills
Additional Information :
All your information will be kept confidential according to EEO guidelines.
PAY RANGE: $90000 $130000 USD Annual Salary
For US Benefits CLICK HERE.
Nemera is an equal opportunity employer and does not discriminate against any person on the basis of race religion color gender gender identity sexual orientation age national origin disability veteran status or any other protected class indication. This company is required by federal law to hire only persons who can establish they are eligible to work in the United States.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
