Senior Quality Engineer
About The Position
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.
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
Responsibilities
- 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
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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
