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Laboratory Quality Control R&D Specialist
2 months ago
Company Overview:
Quantimetrix is a reputable family-owned enterprise dedicated to the design, development, and manufacturing of clinical laboratory quality controls. With nearly five decades of experience, we pride ourselves on delivering exceptional products and services to the healthcare sector.
Position Overview:
We are seeking a qualified individual to fill the role of Research and Development Associate within our esteemed R&D department. This role is pivotal in supporting the development of innovative laboratory quality controls and managing the lifecycle of products post-launch. The successful candidate will be expected to execute tasks autonomously with minimal oversight.
Contract Duration: This is a contract position lasting over six months, with the possibility of transitioning to a permanent role.
Key Responsibilities:
- Conduct feasibility studies, design characterization, and verification and validation testing for new product initiatives.
- Plan, source, and oversee the materials necessary for various studies.
- Draft comprehensive test protocols and reports.
- Analyze data and present summaries effectively.
- Facilitate the transition of new products to the manufacturing phase.
- Provide technical assistance for regulatory submissions and post-launch re-registrations.
- Support post-launch activities including complaint investigations, CAPA, and product enhancements.
- Maintain laboratory equipment and testing instruments, contributing to daily laboratory upkeep.
- Undertake additional responsibilities as assigned.
Qualifications:
- A minimum of two years of experience in a medical device environment, with a preference for knowledge in design control and cGMP.
- Proficient in drafting technical documentation.
- Strong analytical and technical skills.
- Detail-oriented with a proven ability in troubleshooting and problem-solving.
- Excellent writing and communication abilities.
- Familiarity with Microsoft Word, Excel, and PowerPoint.
Educational Requirements:
Bachelor's degree in biochemistry, chemistry, clinical chemistry, or a related field.
Compensation:
The hourly wage for this position ranges from $25 to $35, contingent upon factors such as experience, skills, education, certifications, and location.
