Quality - Sr Quality Engineer

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