职位描述

Seeking a passionate leader of self, people & process, and organization with the following attributes:

• Partners in setting direction for the group : Partner with business leader to set overall direction for the New Product Development group. He should add value to the product and deliver on Stryker’s mission and strategic imperatives.
• Inspires others :   Relationship-focused leader who connects, collaborates and fosters an inclusive environment of enthusiasm, trust and pride.
• Champions talent development.  Focus on maximizing the ability, potential and contributions of themselves and others.   Fosters an environment where people can excel through developing, coaching and rewarding performance.
• Delivers results.  A driven player/coach who sets high goals for personal achievement and organizational success.  He/she measures success against the best internal and external benchmarks.
• Driven to create something new – Group and Product

Position profile

• Sr. Manager Quality Operations

Responsibilities and duties

• Responsible for Quality function and develop new systems and procedures for NPD group.
• Responsible for operations support, supplier development, incoming efficiencies, and regulatory compliance.
• Support products development and customer experience including issue investigation, corrective action, preventive action and risk management.

• Manage supplier quality processes and resolution of supplier issues

• Communicate and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are met.
• Influence the organization across departments (i.e. Sourcing, Quality, Regulatory) to support supplier quality strategy and make sound decisions on supplier strategy and site direction.
• Manage and provide updates for supplier quality metrics. Drive continuous improvement activities to meet and exceed these metrics.

Experience/skills required

• Bachelor’s in a science, engineering or related field.
• Minimum of 15 years relevant quality experience in GMP manufacturing environment in Medical Device, Pharma, Automotive, Consumer Durable  or Aerospace industry Supervisory experience preferred.
• Thorough knowledge of current regulations, pertinent regulatory guidance and industry trends.
• An understanding of the technical aspects of the areas – understand the process, operational terminology etc.
• Experience in quality management systems is essential.
• Must have experience in using PFMEA’s, Control Plans, & Process Flows.
• Physical & Mental requirements:

• Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements.
• Demonstrated written, verbal, listening, communication, and team-building skills.
• Demonstrated ability to collaborate effectively with and lead cross-functional teams.
• Demonstrated ability to effectively prioritize and manage multiple project workloads.
• Demonstrated experience with trending and analysis reporting.
• Demonstrated knowledge of adverse event reporting, complaint investigation, CAPA, and corrective action processes.
• Demonstrated leadership skills.
• Demonstrated supplier process improvement and supplier management skills.