5824 - Device Complaints Support / Validation Engineer 2

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues


• We commit to client success at every turn


• We have the courage to do the right thing


• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.


• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Validation Engineer 2 / Device Complaints Responsibilities:

• Support handling customer complaints. Objectives include:
  
  
  
  • Support timely completion of product complaint investigations, in compliance with global and local procedures.
  
  
  • Assess incoming complaints and determine next steps needed to adequately address the complaint issue(s) in a timely manner.
  
  
  • Determine the appropriate level of return sample analysis needed.
  
  
  • Perform visual and/or functional analysis as needed.
  
  
  • Verify and close relevant complaints with minimal supervision. 
  
  
  • Support inventory management of complaint samples.
  
  
  • Support QA personnel in writing GMP documents, and completing complaint process metrics, including second person verification (SPV) of complaints data.
  
  
  
  


• Conduct PM activities in the Life Science Industry ensuring the project meets the demands of the client.


• Understand Lifecycle management for Quality Applications.

Requirements:

• Must be willing to work onsite in Indianapolis, IN.


• Associate's degree in Engineering, Life Sciences, or a related field.


• Strong computer literacy in all Microsoft Office applications.


• Strong attention to detail.


• High degrees of self-management and problem solving.


• Ability to work under tight deadlines


• Strong interpersonal skills and extremely resourceful

Additional Preferences:

• Knowledge of regulatory requirements (e. g. cGMP, 21 CFR 820, ISO 13485, Canadian MDR)


• Knowledge of complaint handling and quality systems; device/combination product complaint experience preferred


• Veeva QualityDocs experience

Benefits

Why Choose Verista?

• High growth potential and fast-paced organization with a people-focused culture


• Competitive pay plus performance-based incentive programs


• Company-paid Life, Short-Term, and Long-Term Disability Insurance.


• Medical, Dental & Vision insurances


• FSA, DCARE, Commuter Benefits


• Supplemental Life, Hospital, Critical Illness and Legal Insurance


• Health Savings Account


• 401(k) Retirement Plan (Employer Matching benefit)


• Paid Time Off (Rollover Option) and Holidays


• As Needed Sick Time


• Tuition Reimbursement


• Team Social Activities (We have fun!)


• Employee Recognition


• Employee Referral Program


• Paid Parental Leave and Bereavement

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For more information about our company, please visit us at Verista.com