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Laboratory Quality Control R&D Specialist
2 months ago
Company Overview:
Quantimetrix is a family-owned enterprise dedicated to the design, development, and manufacturing of clinical laboratory quality controls. With nearly 50 years of experience, we pride ourselves on delivering top-tier products and services to the medical sector.
Position Summary:
We are seeking a qualified individual to contribute to our Research and Development division. The R&D Associate will play a crucial role in the advancement of laboratory quality controls and the management of products throughout their lifecycle post-launch. This role requires the ability to execute tasks independently with limited oversight.
Key Responsibilities:
- Conduct feasibility studies, design characterization, and verification and validation testing for new product development.
- Plan, acquire, and oversee materials necessary for research activities.
- Prepare test protocols and comprehensive reports.
- Analyze data and present summaries effectively.
- Assist in the transition of new products to manufacturing processes.
- Provide technical assistance for regulatory submissions and post-launch re-registrations.
- Support post-launch activities including complaint investigations, CAPA, and product enhancements.
- Maintain laboratory instruments and equipment, contributing to daily laboratory upkeep.
- Undertake additional responsibilities as required.
Qualifications:
- At least 2 years of experience in a medical device environment, with a preference for knowledge in design control and cGMP.
- Capability to draft technical documentation proficiently.
- Strong technical and analytical abilities.
- Detail-oriented with a background in troubleshooting and problem resolution.
- Excellent writing and communication skills.
- Proficient in Microsoft Word, Excel, and PowerPoint.
Educational Requirements:
Bachelor's degree in biochemistry, chemistry, clinical chemistry, or a related discipline.
Contract Duration:
This position is a contract role with the potential for extension.
Available Positions:
Two positions are open for this role.
Compensation:
The hourly wage for this position ranges from $25 to $35, influenced by factors such as experience, skills, education, certifications, and location.
