Complaints Investigator, QA Technician II (shift A)
Boston Scientific
Coyol, A, CR
hace 2 días

Additional Locations : Costa Rica-Coyol

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges.

With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing whatever your ambitions.

About the Role :

Provide technical support to to the QA Laboratories (Microbiology, MTAC, Complaints).

Your Responsibilities Include

  • Coordinate and perform testing (proficient use of QA laboratory equipment) associated with respective QA Laboratories and correctly record data, write and review reports, and communicate results precisely, promptly and in a timely manner.
  • Support process and equipment qualification activities, test method design, as well as perform intermediate-advanced statistical analysis and communicate correclty documented results to teams.
  • Also define training requirements for these activities and execute training.

  • Coordinate audit activities and rerve support roles during external audits : Document retriever, auditee.
  • Lead product failure analysis (i.e significant support on CAPA activities, initiate and assist in development and completion of NCEPs) and involve required assistance if required.
  • Create, maintain and update data files and forms, databases, spreadsheets and forms, such as the maintenance of the lab s record file in order to ensure proper record flow, track and monitor department activities.
  • If necessary, required to escalate concerns, trends and emerging issues that need addressing.

  • Use documentation systems to research information and generate document changes, as well as use scientific knowledge to read and interpret SOPs and Work instructions in order to perform laboratory tests according to the requirements established in the lab
  • Microbiology) Coordinate material receiving, acceptance and disposition.

    CIS) Conduct complaint investigations as per requirements.

  • Identify, prioritize and resolve quality issues identified by metrics.
  • Coordinate the preventive maintenance tasks on equipment and verify compliance of these task for respective functional unit by week's end.
  • Take, preserve, analize and provide follow up to units / samples. Use good laboratory practices to ensure accuracy of results.
  • Look for the adequate help when needed and create the communication channels for the required support.

  • Identify and lead departmental initiatives related to best quality practices and continuous improvement.
  • May execute additional responsibilities related to the QA Cross Training STAR Project COY1015. Refer to the document by accessing P : DESCRIPTIONS
  • What We’re Looking For :

  • Technical Competency.
  • English Level required : 70% or higher, both writing and spoken.
  • Excellent customer service and customer-centered communication skills, planning and execution skills to determine the right priority for day-to-day tasks and ability to promptly identify and escalate any conflicts is required.
  • Previous participation in Problem-Solving sessions and understanding of Root Cause Analysis tools and methodologies is highly desirable (Ishikawa, 6M’s, 5 Why’s).
  • Knowledge of Operational Excellence principles, understanding and previous experience with Process Improvement initiatives is a plus (Kaizen events or other)
  • At least 5 years of experience in similar position.
  • Or an equivalent combination of experience and education
  • Requisition ID : 540300

    As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most united by a deep caring for human life.

    Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.

    Now more than ever, we have a responsibility to apply those values to everything we do as a global business and as a global corporate citizen.

    So, choosing a career with Boston Scientific (NYSE : BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

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