Senior Quality Engineer

Role Overview

• 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 follow-up 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 cross‑functional 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.

Requirements

• Bachelor’s Degree in Engineering, Life Sciences, or a related technical discipline.
• 7+ years experience in a quality role within an ISO‑certified 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.

Benefits

• 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.