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R&D Quality Control Specialist

2 months ago

Redondo Beach, California, United States Quantimetrix Full time

Company Overview:

Quantimetrix is a 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 medical field.

Position Summary:

We are seeking a qualified individual to fill the role of Research and Development Associate. This position is integral to the advancement of our laboratory quality controls and involves overseeing the product lifecycle management after launch. The ideal candidate will demonstrate the ability to work autonomously with minimal oversight.

Contract Duration:

This role is structured as a contract for a duration of 6 months, with the possibility of transitioning to a permanent position.

Key Responsibilities:

  • Conduct feasibility studies, design characterization, and verification and validation testing for new product initiatives.
  • Plan, acquire, and manage necessary materials for research activities.
  • Draft comprehensive test protocols and detailed 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, corrective actions, and product enhancements.
  • Maintain laboratory instruments and equipment, contributing to daily maintenance tasks.
  • Execute additional responsibilities as required.

Qualifications:

  • A minimum of 2 years of experience in a medical device environment, with a preference for knowledge in design control and cGMP.
  • Proficient in drafting technical documentation.
  • Strong technical and analytical capabilities.
  • Detail-oriented with a proven track record in troubleshooting and problem-solving.
  • Excellent writing and communication skills.
  • Familiarity with Microsoft Word, Excel, and PowerPoint.

Educational Requirements:

Bachelor's degree in biochemistry, chemistry, clinical chemistry, or a related discipline.

Compensation:

The hourly wage for this position ranges from $25 to $35, influenced by factors such as experience, skills, education, certifications, and location.