Director, Distinguished Engineer
Capital One
CloudGoJavaJavaScriptPythonSwiftTypeScript
Director – Chemistry Commercial Product Quality
Siemens Healthineers
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $172,690 - $259,030 per year
Job Level
Lead
About the role
- Responsible for leading the CLS Chemistry Commercial Product Quality (CPQ) Team
- Ensuring compliance with applicable regulations and standards
- Drive product safety, product quality, and customer satisfaction related decisions
- Establish short- and long-term goals to improve complaint resolution, product reliability, and customer satisfaction
- Training and development of group members
- Driving continuous improvement and excellence in results for Key Performance Indicators (KPIs)
Requirements
- Typically, 8+ years of successful experience in related field
- Direct experience in the in-vitro diagnostics industry
- Strong knowledge in complaint handling, investigations, medical device reporting, field action and CAPA processes.
- Detailed understanding of FDA 21 CFR 820, 21 CFR 803, 21 CFR 806, ISO 13485, MDSAP, and EU IVDR requirements.
- Strong technical knowledge of supported product lines.
- BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience.
Benefits
- medical insurance
- dental insurance
- vision insurance
- 401(k) retirement plan
- life insurance
- long-term and short-term disability insurance
- paid parking/public transportation
- paid time off
- paid sick and safe time
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
complaint handlinginvestigationsmedical device reportingfield actionCAPA processesFDA 21 CFR 820FDA 21 CFR 803FDA 21 CFR 806ISO 13485MDSAP
Soft skills
leadershiptraining and developmentcontinuous improvementcustomer satisfactiongoal setting
