Senior Quality Assurance Specialist

2 weeks ago


Cambridge, Massachusetts, United States Aequor Full time

Senior Quality Assurance Specialist

Location: Remote

Terms: Contract W2

Duration: 12 Months Contract (Potential for Extension)

Overview:

This role offers a flexible schedule with a requirement for onsite presence at least two days per week.

Working Hours: Monday to Friday, 8:00 AM - 5:00 PM (flexible)

Ideal Candidate Profile:

The ideal candidate will possess over 4 years of relevant experience, particularly in validation, methodologies, and quality assurance within the medical device sector. Experience in project management is essential. A background in biomedical, electrical, or mechanical engineering is advantageous.

Preferred Qualifications:

  • Bachelor's or Engineering degree with prior experience in the medical device or pharmaceutical fields.
  • A minimum of 5 years of hands-on experience with engineering processes and quality assurance tools.
  • Significant contributions to or leadership in projects from development through regulatory approval processes.
  • Expertise in generating material and test specifications, writing protocols and reports, and developing processes and tests.
  • Experience in product design and development, particularly for European and US regulatory submissions.
  • Proficiency in designing and developing test or inspection methods, including small-scale device assembly and benchtop testing.
  • Familiarity with Automated Test Equipment (ATE) and Measurement Systems Analysis principles.
  • Experience managing deviations, CAPAs, change controls, and document reviews.

Skills Required:

Strong analytical thinking, problem-solving abilities, risk assessment, and risk management skills are crucial. The candidate must be adept at managing multiple projects in a fast-paced environment.



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