Quality - Sr Quality Engineer

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 Monitoring • Participating in CAPA Projects • Participate in validation & measurement capability projects. • Update procedures as required. • Identify and perform continuous improvement projects. • Product line ownership • Execute validations. • Create control plans and PFMEAs. • Perform Internal Audit • Perform Supplier Qualification and audits. • Customer-facing role, running Drumbeat customer meetings. • Leadership role, direct reports of Inspectors or Technician • Owner of Critical Quality Subsystems • Act as SME in regulatory inspections. Job Requirements: • Bachelor's Degree or equivalent experience • 7-10 years in Quality or related engineering roles within manufacturing environments • Ability 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 QMS • Solid understanding of Quality System Regulations (complaint, NCR, containment, root cause, etc.) • Functional Quality statistical knowledge (AQL, sampling, etc.) • Proficient with QMS • Strong leadership abilities • Capable of independent project management Benefits: • New employees are eligible for the following benefits effective date of hire! • Medical, dental, and vision benefits • Company-paid life insurance and disability benefits • Generous Paid time off and 10 paid Holidays • 401k Plan with Company Match • Tuition Reimbursement • Voluntary Universal Life and Long-Term Care • Voluntary Legal Plan • Pet Insurance • Home 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.