Quality Assurance Associate

28 Mar 2024

Vacancy expired!

Mastech Digital provides digital and mainstream technology staff as well as Digital Transformation Services for all American Corporations. We are currently seeking a

Quality Assurance Associate for our client in the

Health Technology domain. We value our professionals, providing comprehensive benefits and the opportunity for growth. This is a

Contract position, and the client is looking for someone to start immediately.

Duration: 6+ Months Contract

Location: San Diego, CA - 100% in Office

Salary: $24.00/Hourly

Role: Quality Assurance Associate

Primary Skills: Quality Assurance

Role Description: The

Quality Assurance Associate must have at least 3+ years of experience. Complaint handling - Mostly closing complaints, fielding complaints (possibly 50 complaints a day using the database). Will be trained on what to look for to assess complaints. Scientific BG, dont need to have experience, you will be trained.

Responsibilities: - Screening complaints record and processing the records per Standard Operating Procedure (SOP) requirements - Assess at minimum incoming Instrument/ Ancillary/ Fulfilment Product Quality Complaints in a timely manner as per procedure. - Escalate potential issues/ incidents to supervisor or higher-level Quality Specialists, including but not limited to Field alerts, MDRs or possible recall situations. - Processes simple corrective/preventive action records to support complaints, audit observation, and process improvements. - Works on problems of minor to moderate scope. - Proposes, plans and executes MyCIs. - Escalates issues to investigation owner for further processing, as deemed necessary. - Determines product complaint root cause codes based on the issue and severity of the complaint. - Performs queries to provide complaint and ad hoc trend analysis on reported product problems. - Ensures training is completed in a timely manner. - Ensures data is accurate, timely, relevant, and complete. - Interacts/coordinates with and supports other departments and build productive working relationships with internal stakeholders. - Ensures no past due records; Assist in preparation of data packets for internal audits and regulatory agencies inspections. - Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations. - Assists in development, maintenance, and reporting of department metrics - Assist in developing/updating department procedures and other controlled documents.

Required Experience: - Experience in the healthcare/device industry or exposure to medical device quality system regulations is preferred. - Must demonstrate initiative, balanced assertiveness, flexibility and team orientation. - Prior experience processing medical device or drug complaints preferred. - Strong interpersonal skills. - Organizational skills and knowledge-based PC computer skills essential, such as industry recognized complaint management systems, MS Access and Excel. - Bachelors Degree is preferred, preferably in a healthcare related field. - Associates Degree can be considered with additional years of relevant experience.

Education: Bachelors degree in Computer Science, Electrical/Electronic Engineering, Information Technology or another related field or Equivalent

Experience: Minimum 3+ years of experience

Relocation: This position will not cover relocation expenses

Travel: No

Local Preferred: Yes

Note: Must be able to work on a W2 basis (No C2C)

Recruiter Name: Srinivas Rao

Recruiter Phone: 412-684-6336

Equal Employment Opportunity

Minimum Education Required: Bachelor

Years of Experience Required: At Least 3 Years

Expected Travel Time: None

  • ID: #49569833
  • State: California San diego 92132 San diego USA
  • City: San diego
  • Salary: $24.00 per hour
  • Job type: Contract
  • Showed: 2023-03-28
  • Deadline: 2023-05-27
  • Category: Et cetera