Technical Support Scientist

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions that detect disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 5,000 team members across 12 sites or subsidiaries, including Salt Lake City based BioFire Diagnostics and Astute Medical. We believe in the power of diagnostics and bioMérieux sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health across the globe.

Astute Medical, Inc. is an in-vitro diagnostics company dedicated to improving the diagnosis of high-risk medical conditions through the identification and validation of protein biomarkers that can serve as the basis for novel in-vitro diagnostic tests. To support the commercialization of its novel biomarker products, Astute Medical is seeking an energetic, experienced, compliance-driven, and self-motivated individual for the position of Technical Support Scientist. Come be a part of our mission to help save lives.

Position Summary:

The Technical Support Scientist will work across cross-functional departments to ensure the successful implementation of quality and business processes at Astute Medical. Specifically, the role will focus on data collection / analysis / communication to support Astute’s Technical / Customer Support and Supplier Management Teams.

Essential Duties and Responsibilities:

This position is responsible for the following:

• Investigations into customer complaints and product/equipment performance issues.  Investigations require ability to effectively streamline questions to obtain required information from appropriate external/internal persons, design and perform technical investigations, perform root cause analysis and risk assessment, and document/communicate associated findings (both electronic and paper-based documentation is required).
• Author, review, and coordinate review of supplier assessments and evaluations.
• Lead weekly complaint meetings and meetings with end-use customers/internal personnel as required. Perform associated follow-up (e.g. meeting minutes)
• Ensure communication and plans are coordinated across multiple teams and with external suppliers.
• Providing knowledge and information (written, electronic, and oral) about Astute Medical’s product lines to customers and to the complaint intake Team.
• Analyze and present data including data associated with complaints, customer satisfaction, and supplier monitoring.  Perform risk analysis based on trends or associated root causes.  Document and present associated results.
• Orchestrate annual customer satisfaction surveys
• Initiate document changes in Astute’s Quality Management System
• Communicate with suppliers to ensure supplier files are current and to ensure progress on supplier corrective actions.
• Participate in Supplier Management Team meetings by documenting minutes and providing information regarding supplier(s)
• Investigate and document root-cause investigations associated with CAPAs, complaint investigations, supplier corrective actions, and customer surveys
• Train personnel within the company and/or Customers on use of Astute products as required as part of complaint investigations or other training programs.
• Review documentation for accuracy and completeness
• Create or contribute towards actions associated with quality or change plan initiatives
• Create and support quality initiatives to maintain an environment of continuous improvement throughout the organization.
• Support Astute Medical’s regulatory team, by following requirements for complaint investigations, field corrections/removals, and vigilance activities.
• Ensure compliance with Company’s Quality Management System.
• Perform other duties & projects as assigned.

Skills, Studies, and Experience:

• Strong technical educational background required; BS degree in science or technical discipline (or RN or BSN degree) or combination of education and experience in IVD or medical device industry.
• 2+ years in the IVD or medical device industry preferred.
• Strong comprehension of the use of medical devices, environment of use and ability to determine if reported issues are reportable based on FDA and international regulations.
• Demonstrated knowledge of appropriate global IVD regulations, requirements, and standards, such as 21 CFR Part 820, ISO13485, ISO14971, European IVDD, & IVDR.  Prior experience with managing IVD complaint files is preferred. Attention to detail and appreciation of Quality System Regulations is critical to this position.
• Ability to work independently, exercise sound judgment, manage diverse and conflicting priorities and projects in an effective manner, and meet deadlines.
• Strong communication skills (verbal & written) including ability to interact positively with all levels of an organization – internal and external.
• Ability to review extensive complaint information, think critically and determine the best course of action.
• Skilled at reviewing, trending, analyzing and reporting data using databases and/or Excel.
• Patience; ability to be able to review procedural steps with a customer without sounding hurried or impatient
• Proficient with Microsoft Office suite. Prior experience with Sharepoint and SalesForce.com (CRM360) and Track-Wise Digital, preferred.

Additional Information:

While performing the duties the employee is:

• Constantly required to sit or stand and answer telephones for long periods of time. 
• Constantly required to reach and work on a computer and standard office equipment.
• Constantly required to communicate with others; internally and externally (verbal and written).
• Frequently required to work flexible hours. 
• Occasional travel

Employee frequently works in an office environment with a moderate amount of noise and activity. The work environment is fast-paced and demanding. Workweeks exceeding 40 hours are required as necessary.

Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.

Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. Our Group offers numerous possibilities: so come and join the 13,000 bioMérieux team members who already identify with these values!

bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.