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5734- Project Manager (Complaint Investigation) / Senior Quality Specialist

Fishers, IN

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

Project Manager (Complaint Investigation) Responsibilities:

This individual will have the regulatory experience to oversee the complaint investigation process and will possess the knowledge and ability to successfully navigate complex complaints. The individual will serve as point of contact to ensure timing/objectives are being met.

  • Senior member of the team providing technical guidance to other team members
  • May support multiple projects scheduled simultaneously
  • Review and sign off on competed complaint investigations
  • Provide effectiveness check information as required
  • Review and investigate complaint information provided
  • Perform visual/functional assessment as required
  • Utilize TrackWise to record and document Complaint History
  • Research Deviation, Batch Record Review, Design History File/FMEA Review, Product Safety Assessment and Product Impact Evaluation background information pertaining to complaint
  • Contact data stewards in order to gain more insight into complaint and gather data as needed
  • Utilize Root Cause Investigation Summary and CAPA Overview as necessary to inform investigation
  • Author Templates for basic complaints and complex complaints
  • Utilize Templates to expedite the investigation write-up process for future complaint investigations

Requirements:

  • Demonstrated capability to deliver on the Senior Quality Specialist Responsibilities
  • Excellent knowledge of Quality system principles; FDA Quality System Regulations (cGMP); ISO 13485 Quality system standards for medical devices or ISO 9001 Quality Management Systems and IS014971 Risk Management Systems required
  • Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate
  • Experience and capability of effectively communicating requirements (written and orally) with a rationale to different levels of the client’s organization
  • Demonstrated project leadership capabilities
  • Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate
  • Experience and capability of effectively communicating requirements (written and orally) with a rationale to different levels of the client’s organization
  • Demonstrated ability to generate high-quality project deliverables independently by required due dates
  • Capacity to identify issues and proactively elevate to the project lead
  • Advanced Microsoft WORD, EXCEL, and PowerPoint capabilities
  • Minimum 5-8 years of role relevant experience
  • Quality certification from reputable agency - required

 

 

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

*Verista is an equal opportunity employer.

National (US) Range

$70,491 - $123,511 USD

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

Verista collects and processes personal data in accordance with applicable data protection laws.  If you are a California Job Applicant, see the privacy notice for further details. 

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

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