Senior Quality Engineer

The Senior Quality Engineer supports the development, maintenance, and continuous improvement of the work site's Quality Management System (QMS). This position is focused on learning and assisting with routine quality activities such as document control, internal audits, CAPA, change control, nonconforming product, and customer complaint tracking. The Senior Quality Engineer will gain exposure to FDA, ISO, and other regulatory requirements.

Hybrid from Carrollton, TX

• Take lead in maintaining QMS documentation (SOPs, work instructions, forms) and ensuring document control activities are current for the site.
• Coordinate design reviews with Engineering.
• Support the change control process which includes preparing change requests, routing for review, and filing records.
• Participate in internal, external, and supplier audits and audit followup as well as documenting findings and tracking corrective actions under guidance.
• Lead investigation of customer complaints and document results in the complaint handling system. Work with Engineering to prepare Failure Analysis reports if necessary.
• Help manage CAPAs which includes collecting data, drafting CAPA records, monitoring implementation progress, and verifying effectiveness.
• Maintain calibration and training records for equipment and personnel as assigned.

• Participate in quality improvement projects and crossfunctional team meetings as directed.
• Assist in preparing for external audits and inspections.
• Support regulatory submission activities by gathering and assembling required QMS records.
• Support on-site reliability testing.

• Bachelor's Degree in Engineering, Life Sciences, or a related technical discipline.
• 7+ years experience in a quality role within an ISOcertified environment or manufacturing setting.
• Familiar with basic quality tools and terminology (e.g., audit, CAPA, document control).
• Proficiency with Microsoft Office Suite.
• Ability to organize, take notes, and manage Microsoft Teams meetings with domestic and international team members.
• Interpersonal skills including effective collaboration and communication skills.
• Adaptable with the ability to work in an ever-changing environment.

• Experience working in an ISO 13485:2016 or FDA 21 CFR Part 820 environment.
• Internship, coop, or job experience in a medical device or regulated industry.
• Experience with electronic QMS platforms.
• Experience with contract manufacturing.

• Infrequent domestic travel, approximately once a month. Short-notice travel is required to accommodate and prevent customer process disruption.

• Comprehensive benefits package including medical, dental, and vision insurance.
• Generous Paid Time Off including paid holidays and floating holidays.
• 401(k) employer match on retirement planning.
• Hybrid working schedule for eligible positions.
• Tuition reimbursement on approved programs.
• Flexible and health spending accounts.
• Talent Development program.