Purpose and Passion
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level.
With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges.
Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose improving lives through your life’s work.
About the Role :
Provide technical support to to the QA Laboratories (Microbiology, MTAC, Complaints).
Your Responsibilities Include
Coordinate and perform testing (profficient 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 intermidiate-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 :
English Level required : 60% or higher, both writting 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