Siemens Healthineers

We pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Director – Chemistry Commercial Product Quality

DirectorDirectorFull TimeRemoteTeam 10,001+H1B No SponsorCompany SiteLinkedIn

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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