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Immediate Hiring for Biocompatibility SME in Warsaw, IN location at Warsaw, Indiana, USA
Email: [email protected]
From:

David Johnson,

concord it systems

[email protected]

Reply to:   [email protected]

Role: Biocompatibility SME (Minimum 6 years)

Location: Warsaw, IN (Day 1 Onsite)

Job Description:

The candidate shall be responsible for: Biocompatibility assessment and organization of respective testing for medical devices
Supporting resolution of biological evaluation issues for current manufacturing facilities and for new product development
Internal technical document creation and approval
Supporting Complaints investigations, CAPAs, and other general technical support duties required within the team
Creating Technical Reviews, specifications and other mandatory documents for regulatory submissions
Reviewing and preparing of procedures to keep pace with standards development
Representing the company via presentations to groups of experts, societies, regulatory bodies and at international meetings.
Helping in development and generating material for staff training and data presentations
Maintaining relevant scientific and medical knowledge by attending conferences, courses and meetings
Educating internal colleagues across departments and divisions in the area of biological safety evaluations, risk assessments, and chemical characterization.
Providing support for key opinion leaders

Required Skillset(s) :

Competency as subject matter expert in biocompatibility domain
Working knowledge of analytical chemistry
Has a comprehensive record of external training in area of competence
Prior experience with risk assessment of manufacturing materials
Has proven competency in presenting subject matter to expert groups and key opinion leaders in a clear and convincing matter.
Has experience in conveying complex scientific topics in a clear and comprehensible fashion.
Strong problem solving skills.

Preferred Skillset(s) :

Knowledge/Experience in dealing with Polymers and their biocompatibility (Good to have)
Experience in medical device research (Orthopaedic industry preferred)

Roles and Responsibility:

Able to effectively resolve conflict between two or more parties
Able to analyze all aspects of a situation, identify potential solutions, and implement the best solution in a timely manner
Goes beyond existing knowledge base and expands our understanding, methods, and procedures, leaving a base for others to utilize and build upon (trailblazing)
Demonstrates ability to balance needs of all departments to meet customer expectations and project schedules
Demonstrates an ability to utilize resources efficiently
Demonstrated ability to represent the company to accomplish objectives even during disagreements
Is professional, concise, and sensitive in accomplishing objectives.
Is able to diplomatically negotiate with a requester regarding what they want in design, process, scope or timetable
Demonstrates strong written and verbal communication skills including presentation skills.
Has ability to tailor the information to the audience and answer with confidence and authority scientific questions
Handles discussions of complex topics with confidence
Demonstrates ability to discuss sensitive information with and tailor communication style to listeners perspectives, including management, surgeons, and external contacts
Shows leadership skills and initiative

Thanks & Regards

David Johnson

Sr.IT Recruiter

Desk Number: +1 209 706 0814

Concord Id :[email protected]

Keywords: information technology Idaho
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Wed Jan 18 22:21:00 UTC 2023

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Location: Warsaw, Indiana