Quality - Sr Quality Engineer

Quality - Sr. Quality EngineerJob 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