Manager, Quality Process Operations
Terumo Blood and Cell Technologies
full-time
Posted on:
Location Type: Office
Location: Littleton • Colorado • 🇺🇸 United States
Visit company websiteSalary
💰 $114,600 - $143,200 per year
Job Level
Mid-LevelSenior
About the role
- Lead a high-impact team driving excellence in medical device manufacturing
- Oversee line-side quality supervisors and technical experts
- Translate global regulations into actionable policies while championing compliance and continuous improvement
- Own critical Quality Management System processes including CAPA, complaint handling, audits, and post-market surveillance
- Influence organizational priorities and spearhead digital transformation initiatives
- Serve as Subject Matter Expert and Process Owner during audits and inspections
- Manage a team of direct reports in support of the Quality Management System
Requirements
- Bachelor's degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job
- Minimum 5 years experience in Quality Assurance and/or Regulatory Affairs involving US FDA Class II or Class III sterile medical device (or Drug) manufacturing
- Minimum 2 years supervisory experience
- Preferred minimum 7 years experience in relevant fields
- Preferred training in FDA Quality System Regulation and ISO 13485
- Preferred training in Lean Six Sigma (Black Belt/Green Belt)
- Preferred demonstrated leadership with digital transformation projects
- Preferred experience with high volume automated production in a regulated environment
- Preferred experience with Windchill, Blue Mountain, Kneat, MiniTAB and/or SAP
Benefits
- Multiple group medical, dental and vision plans
- Robust wellness program
- Life insurance and disability coverages
- Variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance
- 401(k) plan with a matching contribution
- Vacation and sick time programs for associates
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality AssuranceRegulatory AffairsCAPAcomplaint handlingauditspost-market surveillanceFDA Quality System RegulationISO 13485Lean Six Sigmadigital transformation
Soft skills
leadershipteam managementinfluencecommunicationorganizational prioritieschampioning compliancecontinuous improvement