Senior Quality Validation Specialist

1 week ago

Bloomington, United States Verista Full time
Quality Assurance Role

In this challenging position, you will play a critical role in ensuring the quality and compliance of our products and processes.

About Verista:

  • We are a fast-paced organization with a people-focused culture that values growth and innovation.
  • We work closely with clients across the life sciences industry to provide solutions that empower informed decision-making.

Job Responsibilities:

  • You will be responsible for providing quality oversight and approval of validations, change controls, records, and projects.
  • This position involves providing quality support and oversight on product, process, and equipment-related changes and implementations.
  • You will ensure that facilities, utilities, and equipment used in the support of the Quality System are validated and maintained in compliance with regulatory requirements.
  • Review documentation for accuracy, clarity, consistency, completeness, and compliance.
  • You will plan and complete assignments with a wide degree of difficulty while maintaining milestones established in the project schedule.
  • Analyze data, procedures, and requirements to ensure quality and compliance.
  • Collaborate with alternate functional teams to ensure consideration is given to financial and business outcomes when making quality decisions.
  • You will coordinate activities across multiple project groups.
  • Accept ownership and responsibility for decisions.
  • Provide leadership, guidance, coaching, and training to various functions and colleagues.

Requirements:

  • Bachelor's Degree in Engineering or Technical Field or equivalent combination of education and work experience.
  • 3-6 Years of relevant role-specific experience.
  • Process validation experience and demonstrated use of quality tools/methodologies.
  • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
  • Solid communication (written and oral) and interpersonal skills.
  • Strong project management and leadership skills.
  • Prior medical device validation experience preferred.
  • Experience implementing various product and process improvement methodologies.
  • Ability to work within a team and as an individual contributor in a fast-paced environment.
  • Strong verbal and written communications skills.
  • Multitasks, prioritizes, and meets deadlines.
  • Strong organizational and follow-up skills.
  • Ability to maintain regular and predictable attendance.

Estimated Salary Range: $70,491 - $110,784

Benefits:

  • High growth potential and fast-paced organization.
  • 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.
  • Employee Recognition.
  • Employee Referral Program.
  • Paid Parental Leave and Bereavement.

About Our Location:

Verista is based in Bloomington, IN. This location offers a great balance of work and play, with plenty of opportunities to explore the surrounding area.

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