Senior Quality Engineer

We're 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're 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'll 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.

Job Responsabilities:

Open, investigate, and close NCRs
Open, investigate, and close complaints
Create metric reports as assigned
SPC Monitoring
Participate 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, run 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, chemical, 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 market 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