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