Quality Engineer (Test Method Validation)

Overview:

• Ensures compliance with applicable standards and regulatory requirements (e.g. FDA ISO)
• Leads laboratory-based quality activities including hand on experience with Test Method Validation (TMV) Design Verification (DV) and product testing
• Authors executes and reviews test plans protocols and reports to support product development
• Execute hands-on laboratory testing data analysis and technical investigations
• Collaborates with Design Engineering Regulatory and Laboratory staff to ensure testing activities are appropriately planned executed and documented
• Supports design controls risk management and other quality activities as needed

Responsibilities:

• Author review and execute TMV protocols and reports
• Develop and execute Design Verification plans protocols and reports
• Support hands-on verification and validation testing activities
• Analyze test data document results and communicate findings to project teams
• Investigate test failures deviations and nonconformances; support root cause analysis and corrective actions
• Ensure accuracy completeness and traceability of testing and validation documentation
• Review and approve quality and testing documentation in accordance with development procedures
• Support project teams and laboratory on quality-related activities
• Provide support for other quality activities including design controls and risk management documentation

Qualifications :

Requirements:

• Bachelors or Masters degree in Engineering Science or related field
• 2-4 years of experience in QC laboratory or quality departments within medical device or pharmaceutical industries
• Working knowledge of relevant regulations and industry standards (FDA 21 CFR 820 ISO 13485 etc.)
• Proven experience authoring and executing TMV and DV documentation
• Strong hands-on laboratory testing and data analysis experience
• Strong technical writing and documentation skills
• Experience with statistical analysis tools such as Minitab JMP or equivalent.
• Self-motivated with good communication and organization skills

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 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

POSITION RANGE: $95000- $115000 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