Senior Director Quality Siemens Newark

Job Description
The Senior Director of Quality for Manufacturing at the Newark, Delaware site is responsible for ensuring appropriate quality systems and processes are in place and facilitating the production of quality medical diagnostic testing products in the most efficient manner possible. The Senior Director reports to the Vice President of Manufacturing and functionally to the Vice President of Quality Operations and Compliance. Reporting to this position are Quality Control and Quality Assurance departments encompassing 75 personnel.
The role is responsible the daily operations management for the Quality Assurance, Quality Engineering and Quality Control functions. The role is also the Site Management Representative for reporting the quality status of the Newark Delaware site. This position ensures compliance with ISO 13485:2003, FDA 21 CFR Part 820 and other International Regulatory requirements. Business needs and compliance requirements are met through the delivery and operation of an effective quality management system. An integral part is the implementation and the control of the mandatory elements of Siemens Quality Management and internal assessment. The Sr. Director drives process measurement initiatives, including scorecards and other metrics, which can also be used to drive process improvements. The role leads others in deploying and improving processes, including consulting to process teams and other management teams. The site produces products and supports the following product lines: Dimension, Dimension Vista, ADVIA Clinical Chemistry, SYVA, & Stratus.

Specific area of responsibility/tasks:

Quality Management System: Development, implementation and documentation of a consistent quality management system based on regulatory and quality-related requirements.

Operations Planning & Management: Ensure business-driven planning and an integrated quality plan. Ensure (a) identification of critical business issues, (b) prioritization of improvement projects/actions, (c) realistic budget and resource planning, (d) selection of appropriate financial and non-financial Key Performance Indicators (KPIs), (e) benchmarked target values, and (f) the coordination of personal operational and quality related targets for management, individuals, and/or teams.

Reporting: Using key performance indicators, targets, budgets and process information, plan for and engage appropriate resources to achieve those objectives to the highest quality and cost effectiveness and put in plan effective solutions for those not being met.

Audit and assessments: Ownership for audits, assessments and preparation of management reviews; this includes regular internal and external assessments based on the mandatory elements of Siemens quality management guidelines.

Customer integration: Facilitate methodologies to analyze customer requirements appropriately to identify key KPIs and foster regular customer integration to ensure timely feedback and complaint handling designed to ensure fast complaint routing, effective root cause analysis, timely CAPA initiation and closure, and improved customer satisfaction.

Continuous Improvement: Plan, initiate, coordinate and personally participate in initiatives to ensure continuous improvement activities with Consumables Manufacturing, including ongoing assessment of organizational roles, integration of process and product design, 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.

Consequent supplier management: Ensure supplier management with best management methods in alignment with Supplier Quality Assurance, to increase the delivered quality and reduce the cost of nonconformance. This comprises supplier-related processes like selection, information, development, integration, monitoring and auditing.

Communication: Communicate effectively, providing relevant information in a timely manner, both verbal and written, with direct reports, peers, line management and customer base to build trust and cooperation across the business.

Authority:
• Functional management of all employees of the Glasgow Manufacturing quality management team
• Manage and escalate non-compliance to regulations and quality-relevant performance issues, including product hold
• Access to all quality relevant data e.g. customer contracts, risk assessments, financial data, product plans, and targets for decision making
• Internal and external representation of the quality management system

Ideal candidate has experience in IVDD kit/reagent manufacturing.

Siemens encourages qualified long-term unemployed individuals to apply for open positions.

Offer of employment with Siemens is conditioned upon the successful completion of a background check and drug screen, subject to applicable laws and regulations.

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