Job Description
Specific Requirements:
• Leads others in deploying and improving processes related to Design Controls and Risk Management
• Ensures:
o Identification of compliance issues
o Prioritization of improvement projects/actions
o Realistic budget and resource planning
o Selects appropriate Key Performance Indicators (KPIs)
o Benchmarks best practices
o Establishes personal quality-related targets for management, individuals, and/or teams., including consulting to process teams and other management teams.
• Plans, initiates, coordinates and personally participates in initiatives to ensure continuous improvement activities on Design Controls, including ongoing assessment of organizational roles, quality tools, and best practices. Design and implement a communication strategy to ensure organization-wide understanding of the quality framework and drive a quality-focused culture.
• Participates in audits, assessments and management reviews; this includes regular internal and external assessments based on the mandatory elements of Siemens quality management guidelines
• Ensures effective deployment of Quality Engineering tools for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
• Utilize quality engineering principles and problem solving skills (risk analysis, problem solving methodologies, statistical techniques, etc.) to develop and optimize products/processes that are aligned with the overall Quality and Business vision.
• Provides guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations related to Design Controls, Risk Management, Quality Engineering (e.g., Quality System Regulation, EU IVDD, ISO standards, etc.)
• Provides clear direction to the organization in all areas of Design Controls (e.g. Design Review, Design Verification, Design Transfer, Design Validation, etc.).
• Effectively utilizes Lean and Six Sigma methodologies as appropriate to achieve optimal results
• Communicates effectively, providing relevant information in a timely manner, both verbal and written, with direct reports, peers, and management to build trust and cooperation across the business
General Requirements:
Job Family Responsibilities:
The Director Design Quality Engineering for analyzers is responsible for ensuring appropriate quality systems are in place and facilitating the development and design changes of medical diagnostic products in the most efficient manner possible. This position ensures compliance with ISO 13485:2003, FDA 21 CFR Part 820 and other International Regulatory requirements.
An integral part is the implementation and monitoring of Siemens Quality Management Systems. The role leads others in deploying and improving processes. The Director reports to the head of Design Quality Engineering. Reporting to this position is a group of very experience Design Quality Engineers.
Education:
At a minimum, a BA/BS degree (in a Life Science, Engineering, or Physical Science preferred).
Certifications, Licenses, Registrations:
Certified Quality Engineer (ASQ CQE, CRE or equivalent) preferred
Green Belt or Black Belt certification preferred
Knowledge and Experience:
Demonstrated ability to lead others in combination with comprehensive knowledge of field of specialization to the successful completion of complex assignments. This includes in-depth knowledge of ISO 13485, and FDA Quality System Regulations. Typically 10-15 years of successful experience in related field and successful demonstration of Key Responsibilities.
Direction of Others:
Provides specialized direction to professional staff. Leadership qualities and role model qualities demonstrated.
Key Working Relationships:
Primarily intra-organizational contacts and external contacts.
Monday, September 28, 2015
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