Ensures that the following activities are performed through the management of a team project quality engineers management (up to 10 project quality engineers worldwide)

• Evaluation of customer requirements to identify applicable quality standards
• Initiation of product development notification process and generate quality answer
• Development of quality plans - Lead of risk management activities
• Ensuring design control elements are satisfied
• Ensuring process validation activities are completed
• Define product control strategy
• Ensuring supplier qualification plans have been defined and performed
• Evaluation of test methods used in project activities
• Release product during development activities
• Realization of quality functional reviews
• Continue to build Quality Management leadership and technical capability throughout the organization by integrating, aligning, and increasing the rigor of quality systems across the global organization
• Manage team of Quality Engineers
• Set clear objectives for the PQE team that are aligned with BDM, PS strategic priorities
• Provide and develop the SME’s for problem solving skills related to design and customer issues
• Develop and build QE core competencies and technical capability throughout the QE organization.
• Ensure representation of the quality organization in product design reviews according to applicable procedures
• Support investigation for issues related to product design
• Establish appropriate metrics to measure progress and to define yearly objectives
• Ensure implementation of PS global procedures and standards for QE engineering activities
• Provide support to internal, regulatory body and customer audits and associated corrective actions
• Develop systems, processes, and procedures related to project quality activities
• Supports continuous improvement of current products and practices to improve quality, customer experience, and worldwide market share

Supports:

• Manufacturing sites with appropriate technological, problem solving, and resources to prevent and or minimize adverse situations.
• Customer facing teams by providing technical support
• Interface with the Corporate Quality function
• Can be part of internal or external quality audit team

Main Functional Interactions:

Internal:

• -Functional directors and VP Quality, R&D, Operations, Medical Affairs, Regulatory Affairs
• -Segment leaders
• -Platform (ADDS, PFS) leaders

External

• BDMPS customers
• BDMPS suppliers
• Regulatory bodies

Qualifications:

• Bachelor’s degree in Engineering, or other scientific discipline.
• Seven plus years of medical device, biologic, pharmaceutical, or diagnostic industry experience.
• Management experience is required.
• Ability to coordinate multi-cultural team and to manage and prioritize multiple activities with varying business, compliance and customer drivers
• Advanced understanding of Design Control, Risk management, Project Management, DFSS
• Experience in Quality System, Six Sigma Methodology, Validation, FMEA/Risk Management
• Understanding of industry regulations/standards:  ISO 13485, QSR, GMP
• Knowledge and experience in manufacturing, project management and engineering.
• Product software design, development, regulation awareness
• Strong interpersonal skills
• Rigor and good organization.
• Must possess excellent oral and written communication skills, and supervisory/leadership capability.
• Demonstrated ability to understand and communicate complex technical, statistical and compliance subject matter