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Quality Assurance Compliance Specialist

5 months ago

North Sioux City, United States Innovive Full time

Innovive is a consistently growing manufacturing company serving the biomedical research community. The Quality Compliance Specialist contributes to the success of Innovive through working with suppliers and customers, in addition to the engineering, operations, and supply chain teams. This position requires continuous communication to suppliers to drive design and process improvements as well as responding to customer feedback. This full-time position will support the Quality Manager with maintaining qualified suppliers and improvement of products. We value hard work and credit the team for our success.


Position Responsibilities:


  • Work with suppliers and Supply Chain team to establish and maintain audit schedules for raw material and service vendors.
  • Execute on-site and/or virtual audits of suppliers and third-party manufacturers to assure compliance with product specifications and ISO standards.
  • Provide clear and factual feedback to suppliers in the form of written reports including observations and assessment of corrective and preventive actions to remediate gaps.
  • Participate in/conduct audit activities including opening and closing meetings, establishment of agendas, and coordinating with auditing team members; can include coordination of travel accommodations.
  • Be primary point of contact for Customer Service team for complaint management; act as lead for investigation, root cause analysis and for training and/or communication of issues to production or quality teams as needed.
  • Prepare and submit required quality records and documentation for closure and filing of customer complaints.
  • Be an active member of the internal audit team. Assist in the completion of process audits.
  • Learn and become a point of contact for NetSuite development of quality based modules.
  • Lend support and assistance to the Quality Manager with projects as needed; additional responsibilities to be developed after 1 year of tenure.


Qualifications & Skills:


  • Critical thinking and problem solving skills.
  • Attention to detail.
  • Organizational, planning, and documentation skills.
  • Strong written and verbal communication skills.
  • Brings values and a sense of ownership to the position.
  • Ability to take direction as well as initiative.
  • Team work.


Education & Experience:


  • Experience in quality or systems management.
  • 5 or more years of relevant experience required.
  • Experience in the FDA industry is a plus.
  • Experience working with Google Suite is a plus.



Location: North Sioux City, SD

Compensation: Salary commensurate with experience and highly competitive within the industry.

Employment Type: Full-time, Exempt

Travel: Up to 25%


Benefits Offered: We provide Paid Time Off, Paid Holidays, Medical, Dental, Vision, Life Insurance, Disability Insurance, FSA & HSA, 401k with Company match, EAP, employee discounts and a casual work environment with excellent career growth opportunities.