Operational Quality Assurance Specialist

Centese is an innovative medical device company dedicated to improving patient care through advanced technology and operational excellence. We operate in a highly regulated environment where quality, precision, and teamwork are critical to everything we do. We are seeking a detail-oriented Operational Quality Assurance Specialist to support our Quality Management System (QMS) and help ensure compliance with FDA and ISO standards in a regulated medical device manufacturing environment. This role is ideal for someone who enjoys organization, documentation accuracy, and process support. Responsibilities Maintain and support QMS documentation and records Administer document control processes and version tracking Review production records for completeness and accuracy Support CAPA tracking, nonconformance documentation, and audit preparation Maintain training records and assist with compliance activities Communicate documentation discrepancies and follow up on corrections Support production and shipping documentation review Qualifications 1-2 years of Quality Assurance or regulated manufacturing experience preferred Familiarity with

FDA 21 CFR

Part 820 and/or

ISO 13485

Understanding of Good Documentation Practices (GDP) and GMP Strong attention to detail and organizational skills Ability to work independently and collaboratively in a fast-paced environment Medical device experience is a plus This position is onsite in Omaha, Nebraska. Relocation assistance is not available for this role. Applicants must be authorized to work in the United States without current or future visa sponsorship needs. Local candidates are encouraged to apply. Must pass criminal background check Centese, Inc. is an Equal Opportunity Employer.

Pay:

$25.00 - $28.00 per hour

Benefits:

Dental insurance Health insurance Life insurance Paid time off Vision insurance Application Question(s): Do you have experience with FDA and/or ISO standards? Do you have at least one year of quality assurance experience? Do you have experience with CAPA reviews?

Work Location:

In person