Quality - Sr Quality Engineer

We are a company of agile, customer-oriented individuals with a shared commitment to integrity, servant leadership, and teamwork. Our associates take pride and ownership in their work, and innovate to provide the highest quality, life-enhancing medical technology in the world. Together, we are in It for Life. As a Senior Quality Engineer, you will serve as a key leader and QMS subject matter expert, driving quality excellence across products, processes, and teams. In this role, you will apply your technical expertise, problem‑solving skills, and data‑driven approach to support regulatory compliance, lead critical quality initiatives, and champion continuous improvement. This position is ideal for an experienced quality professional who thrives in a fast‑paced, customer‑focused environment and is committed to delivering safe, high‑performing medical technology. Quality - Sr. Quality Engineer Job Responsibilities: Open, investigate, and close NCRs.Open, investigate, and close complaints.Create metric reports as assigned.SPC MonitoringParticipating in CAPA ProjectsParticipate in validation & measurement capability projects.Update procedures as required.Identify and perform continuous improvement projects.Product line ownershipExecute validations.Create control plans and PFMEAs.Perform Internal AuditPerform Supplier Qualification and audits.Customer-facing role, running Drumbeat customer meetings.Leadership role, direct reports of Inspectors or TechnicianOwner of Critical Quality SubsystemsAct as SME in regulatory inspections. Job Requirements: Bachelor's Degree or equivalent experience7–10 years in Quality or related engineering roles within manufacturing environmentsAbility to lead root cause analysis with cross‑functional teams and drive corrective/preventive actions.Proficiency analyzing data (e.g., in Excel; exposure to Minitab preferred) to inform decisions and reports.Direct experience producing validation reports and translating execution results into clear documentation.Strong time/task management, responsiveness, proactive ownership, and ability to work with changing priorities.Experience in medical device manufacturing; or other broader manufacturing such as plastics, chemicals, or polymer environments.Proficient with math, statistics, and reading comprehension.Proficient with computer skills (Microsoft Office, etc.)Basic understanding of QMSSolid understanding of Quality System Regulations (complaint, NCR, containment, root cause, etc.)Functional Quality statistical knowledge (AQL, sampling, etc.)Proficient with QMSStrong leadership abilitiesCapable of independent project management Benefits: New employees are eligible for the following benefits effective date of hire!Medical, dental, and vision benefitsCompany-paid life insurance and disability benefitsGenerous Paid time off and 10 paid Holidays401k Plan with Company MatchTuition ReimbursementVoluntary Universal Life and Long-Term CareVoluntary Legal PlanPet InsuranceHome Ownership Program We offer competitive compensation. Potential salary range for this role is $130,000-$145,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.