Director, Distinguished Engineer
Capital One
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Director – Immunoassay Commercial Product Quality
Siemens Healthineers
full-time
Posted on:
Location Type: Remote
Location: Remote • California • 🇺🇸 United States
Visit company websiteSalary
💰 $172,690 - $259,030 per year
Job Level
Lead
About the role
- Responsible for leading the CLS Immunoassay Commercial Product Quality (CPQ) Team
- Complaint handling, medical device reporting, and Field Action activities for Atellica IM, Atellica CI and ADVIA Centaur assays
- Developing and executing organizational strategies, processes, goals, and metrics
- Leading cross-functional initiatives to enhance the customer experience
- Training and development of group members
- Establishing short- and long-term goals to improve complaint resolution, product reliability, and customer satisfaction
- On time reporting of medical device reports
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
- Experience in Quality Systems, MDRs and Field Action recommended
- BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience
- Willing to travel 20%
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 handlingmedical device reportingField Action activitiesCAPA processesQuality SystemsMDRsin-vitro diagnostics
Soft skills
leadershiptraining and developmentorganizational strategiescustomer experience enhancementgoal settingproblem resolution
Certifications
BS/BA in related disciplineadvanced degreeISO 13485FDA 21 CFR 820FDA 21 CFR 803FDA 21 CFR 806MDSAPEU IVDR
