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 • 🇺🇸 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 responsible for 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 that drive measurable improvements in complaint handling, product quality, and customer satisfaction.
- Leads cross-functional initiatives to enhance the customer experience, reduce quality issues, and ensure compliance with regulatory and internal standards.
- Serving as a Subject Matter Expert for post market topics, processes and tools.
- Ensuring compliance with applicable regulations and standards.
- Drive product safety, product quality, and customer satisfaction related decisions, with appropriate authority (both data-based and risk-assessment-based decisions).
- Establish short- and long-term goals to improve complaint resolution, product reliability, and customer satisfaction.
- On time reporting of medical device reports.
- Addressing FDA and other NCA concerns with product recalls to achieve the best outcome (regarding recall classification and where applicable, continued product availability).
- Training and development of group members to satisfactorily complete their job activities and career aspirations.
- Driving continuous improvement and excellence in results for Key Performance Indicators (KPIs).
Requirements
- Typically, 8+ years of successful experience in related field and successful demonstration of responsibilities as presented above.
- Demonstrated ability to lead and manage people.
- Direct experience in the in-vitro diagnostics industry.
- Strong knowledge in complaint handling, investigations, medical device reporting, field action and CAPA processes.
- Proven experience covering post market topics in front room external inspections (e.g., FDA, TUV, etc.).
- Detailed understanding of FDA 21 CFR 820, 21 CFR 803, 21 CFR 806, ISO 13485, MDSAP, and EU IVDR requirements.
- Education: BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience.
- 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
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 processespost market topicsinvestigationsproduct qualityproduct reliabilityKey Performance Indicators (KPIs)regulatory compliance
Soft skills
leadershipteam managementorganizational strategycustomer satisfactioncross-functional collaborationcontinuous improvementtraining and developmentcommunicationproblem-solvingdecision-making
