Investigative Analysis Specialist (Medical Device, CAPA, Audits) in Mountain Lakes, NJ at Apex Life Sciences

Date Posted: 10/13/2018

Job Snapshot

Job Description


Medical Device Investigations Specialist (CAPA, FDA, Troubleshooting)

Position Summary

This position will evaluate, investigate and resolve complaints while also analyzing complaint data and gathering additional information as needed. Interact with other teams in a collaborative manner to complete the end-to-end complaints process in a highly regulated environment.  

Excellent technical and communication skills are needed to positively interact with customers and company personnel. Successful candidates will be self-starters, who can independently manage their time and schedules; will possess basic business acumen and effectively communicate skills at all levels.

Position Responsibilities:

  • Document, examine and process the incoming complaints in line with established procedures.
  • Maintain an understanding of information/data required to be collected for technical and non-technical complaints to assure compliance with regulations.  
  • Determine the cause of error; classify the complaints and forward information to the relevant department for processing.
  • Perform data entry and follow-up activities for completeness and timeliness.
  • Coordinate internal and external repair of devices as needed.
  • Participate and collaborate objectively with team members globally to achieve consistent processes while identifying improvements to drive efficiency and compliance.
  • Assist with the administration of the CAPA system. This includes but is not limited to monitoring timely closure of action items, gathering metrics, ensure CAPAs are effectively managed and auditing the files for objective evidence of corrective actions.
  • Display excellent multi-tasking capabilities.
  • Stay current with system information, changes and updates.  
  • Follow standard procedures, guidelines and policies.

Desired Skills & Experience

  • A BS in Life Sciences, Biomedical engineering and / or technical discipline; or equivalent military training and experience, with emphasis in instrumentation, computers.
  • Two or more years’ experience in complaint handling or quality assurance/regulatory compliance or related field is required.
  • Understanding of FDA and ISO Requirements.
  • Technically proficient in running  IVD assays  and an understanding the basis for these assays. 
  • Well-organized, able to function independently, with a minimum of supervision.
  • Exhibits high level of critical thinking abilities.
  • Strong verbal and written communication skills.
  • Strong computer skills (MS Word, Excel, Outlook etc.).

FOR IMMEDIATE CONSIDERATION please email your resume to ganzalone@apexlifesciences.com 

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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