Position Summary:

The position is responsible to ensure that activities throughout the product lifecycle are in compliance with procedures, standards and regulations applicable to our products.  This position provides project-level leadership, develops, applies and implements methods, tools and practices to achieve product quality and compliance goals and requirements in the areas of design, development, production, distribution, maintenance and service.

This is a technically focused role requiring advanced skills in analyzing information, reviewing technical reports, promoting process improvement, compliance to standards, requirements development, risk management, product development and production controls, and understanding of State of the Art in technology and compliance.  This position is expected to lead by example and influence the organization in alignment with the company values to achieve objectives.

Key Accountabilities

Essential Functions:

• Participates in the generation and review of Design History File and Risk Management documents throughout the product lifecycle
• Advises and directs teams regarding compliance to procedures, standards and regulations
• Ensures product quality meets requirements, and documentation is complete prior to approval
• Participates on core teams supporting new product development or design changes
• Defends relevant quality topics in audits and corrective actions to improve and maintain compliance of the QMS
• Interprets regulations and procedures to ensure documents are sound and defensible to auditors and regulatory bodies.
• On projects of significant scope, leads the successful implementation of Design Control and Product Realization requirements for design, production and distribution of Werfen products
• On new product development and or product performance investigations, provides
  guidance on most appropriate tools and techniques available
• Provides input on product requirements, acceptance criteria, traceability, product evaluation, failure investigation and complaint analysis.
• Provides guidance on compliance of software to procedures and standards including
  cyber security and privacy requirements
• Works with Solution Leader, Development, Testing, Marketing, Regulatory, Service, Distribution, Sales & Marketing, and others outside the company (as needed) to recommend or prepare corrective / preventive actions (CAPA)
• May supervise the work of others
• Leads cross-functional projects on technical and quality issues
• Identifies compliance gaps and suggest appropriate corrective actions as needed
• Supports internal and external audits
• Leads quality system improvement projects as required.

Networking/Key Relationships:

This position will work closely with the QA/RA function as well as with all groups within the Digital Solutions Unit, as well as Marketing, Service, Medical Affairs, R&D and other functions across the organization to effectively drive solutions forward. Interactions will include:

• Working closely with other functions to generate compliant documents by interpret- ing and explaining quality procedures, applicable standards, regulations and best practices.
• Effectively communicating quality requirements to a broad population of constitu- ents.
• Negotiating and influencing others in establishing direction toward improved quality and enhanced compliance.

Minimum Knowledge & Experience Required for the Position:

• Bachelor's degree plus a minimum of 12 years related experience of Master's Degree plus a minimum of 9 years related experience or waiver based on experience.
• Additional experience working in or knowledge of:
  • Software Platforms and Applications
    o Project design, validation, quality plans and risk management (including human factors engineering)
  • Preparing submissions, complaint systems and/or authorities reporting activi- ties
• Solid knowledge and experience working with medical device international regula- tions and related standards (ISO 13485, ISO 14971, ISO 62304, etc.)
• Language: English, Spanish (desirable)

Skills & Capabilities:

The ideal candidate for this position will exhibit the following skills and capabilities:

• Deep knowledge of domestic and international quality/regulatory standards related to Digital Medical Device products
• Demonstrates nuanced judgment commensurate with experience regarding application of regulatory requirements to data review, reports, design changes, risk management, etc. to ensure compliance and achieving business objectives. Demonstrated understanding of risk-based approach to processes and decisions.

Competencies:

• Attention to Detail: Ability to pay close attention to detail is required
• Accuracy: Work is accurate and complete
• Performance Standards: Demonstrated ability to meet department goals
• Communication: Excellent written, verbal and presentation skills
• Discretion: Act with integrity in all situations and can maintain appropriate confidentality
• Multi-Tasking: Ability to manage multiple priorities, and support changing business needs
• Collaboration: Ability to work within a multi-function team to bring best solutions to the team or customer
• Independence: self-motivated works under minimal supervision
• Professionalism: Must demonstrate professionalism during all interactions within the company, customers nd third parties
• Takes Initiative: Serves as a role model for " Quality First" by continuously improving on what matters most to customers
• Problem Solving: Promptly and effectively handles issues and problems
• Decision making: Makes decisions based on data and risk determination

Additional Skills and Knowledge: 

• Broad and Through knowledge of engineering and science theory and principles, inclusing R&D, quality control, manufacturing and desin engineering
• Understanding of the application of technical principles and engineering problem solving to resolve complex issues.
• Membership on external standards organizations of industry groups with influence of our products-desirable

Travel Requirements: 

• Up to15% of the time.