Quality Assurance Investigator II Role

hace 2 días


Alajuela, Alajuela, Costa Rica Boston Scientific Corporation A tiempo completo

**Boston Scientific Corporation: Where Quality Meets Excellence**

At Boston Scientific, we pride ourselves on delivering cutting-edge medical solutions that improve patient outcomes. As a leading global developer, manufacturer, and marketer of medical devices, we're committed to innovation and excellence in everything we do.

**Job Summary:** We're seeking a highly skilled Quality Assurance (QA) Investigator II to join our team. In this role, you'll be responsible for providing technical support to our QA Laboratories, ensuring the highest standards of quality and compliance.

**Key Responsibilities:**

- Coordinate and perform testing activities associated with our QA Laboratories, accurately recording data, writing and reviewing reports, and communicating results effectively.

- Support process and equipment qualification activities, test method design, and perform intermediate-advanced statistical analysis, clearly documenting results for teams.

- Define training requirements for these activities and execute training sessions.

- Coordinate audit activities and reserve support roles during external audits: Document retriever, auditee.

- Lead product failure analysis (i.e., significant support on Corrective Action Preventative Action (CAPA) activities, initiate and assist in development and completion of Nonconformance Event Procedures (NCEPs)) and involve required assistance as needed.

- Create, maintain, and update data files and forms, databases, spreadsheets, and forms, such as the maintenance of the lab's record file to ensure proper record flow, track, and monitor department activities.

- If necessary, escalate concerns, trends, and emerging issues that need addressing.

- Utilize documentation systems to research information and generate document changes, as well as use scientific knowledge to read and interpret Standard Operating Procedures (SOPs) and Work Instructions to perform laboratory tests according to established requirements.

- (Microbiology) Coordinate material receiving, acceptance, and disposition.

- (Complaint Investigation Services (CIS)) Conduct complaint investigations as per requirements.

- Identify, prioritize, and resolve quality issues identified by metrics.

- Coordinate preventive maintenance tasks on equipment and verify compliance for respective functional units by week's end.

- Take, preserve, analyze, and provide follow-up to units/samples.

- Employ good laboratory practices to ensure accuracy of results.

- Look for adequate help when needed and create communication channels for required support.

- Identify and lead departmental initiatives related to best quality practices and continuous improvement.

- May execute additional responsibilities related to the Quality Cross Training STAR Project COY1015.



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