Siemens Healthineers
We pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
Director – Chemistry Commercial Product Quality
Location
United States
Posted
152 days ago
Salary
$172.7K - $259.0K / year
Bachelor Degree8 yrs expExperience acceptedEnglish
Job Description
• Responsible for leading the CLS Chemistry Commercial Product Quality (CPQ) Team responsible for complaint handling, medical device reporting and Field Action activities
• Develop and execute organizational strategies, processes, goals, and metrics that drive measurable improvements in complaint handling, product quality, and customer satisfaction
• Serve as a Subject Matter Expert for post market topics, processes and tools
• Ensure 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
• Report medical device reports on time
• Address FDA and other NCA concerns with product recalls
• Train and develop group members
• Drive continuous improvement and excellence in results for Key Performance Indicators (KPIs)
Job 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
- Advanced degree MAY be substituted for experience, where applicable
- 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
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