Quality Engineer

Overview:

• Ensures compliance with applicable standards and regulatory requirements (e.g. FDA ISO)
• Manages manufacturing quality operations supporting the production lifecycle (e.g. DHR batch release risk-based controls)
• Supports additional quality activities such as design controls risk management verification and validation design changes 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)
• Works within established procedures covering quality environmental health and safety confidentiality and good manufacturing practices

Responsibilities:

• Supports and challenges project team on all aspects of quality
• Reviews and approves quality documented in accordance with development procedures
• Leads validation activities and ensures completion of DHR deliverables
• 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 de-risking).
• Follows up and reports project status regularly to the Unit Quality Manager
• Participates in internal audits
• Actively participates in the QMS maintenance and improvement
• 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 leading validation and documentation efforts within a manufacturing environment
• 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
• Self-motivated with good communication and organization skill

Additional Information :

Why Join Nemera

At Nemera we prioritize patients when creating drug delivery devices understanding that accurate dosing and ergonomics are crucial for treatment adherence. Joining Nemera means becoming part of a team that enjoys working together and consistently delivers on its commitments. We take pride in our work because it improves patients lives.

We look forward to receiving your application (resume submitted in English is appreciated). We offer varied jobs job in an international group if you want to discover more about Nemera please look at our website

Know someone at Nemera We have a Referral Program so be sure to have them submit you as a referral prior to applying for this position!

PAY RANGE: $90000 - $105000 USD Salaried (This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.)

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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 :

Full-time