Senior Manager, NC/CAPA

Stryker is hiring a Senior Manager, NC/CAPA to support Joint Replacement (JR)! In this role, you will lead the JR Division NC/CAPA team, driving timely and effective resolution of issues, aligning cross-functional strategies for business-critical matters, and ensuring effective communication with the JR business and key partners.

Workplace Flexibility: Hybrid or Onsite: It is preferred that this person is located near our Mahwah, NJ or Weston, FL site, or within reasonable proximity to a Stryker facility.

What you’ll do:

• Manage the NC/CAPA team to ensure records are addressed effectively and timely.

• Collaborate with cross-functional partners to build consensus for strategies to address key matters that meet patient and business needs.

• Inform JR leadership of status of business-critical issues.

• Identify and implement process improvements to the NC/CAPA process.

• Develop strategies for the NC/CAPA team to continually to continually improve and evolve.  Including but not limited to innovative tools, forums, resourcing, and value add activities.

• You will be the Brand Ambassador for the NC/CAPA’s team value proposition.

• Develop and grow team members through stretch assignments, coaching, and effective constructive feedback.

• Hire and develop NC/CAPA Specialists, as required.

• Ensure solutions are logical and based on problem solving tools.

• Identify areas of opportunity and support the continual improvement of the Quality Management System.

• Participate in activities in support of the division’s continual improvement initiatives.

What you need:

Required:

• Bachelor's degree required. Preferred to be in science, engineering or related field.

• 10+ years of related experience, e.g., quality assurance, manufacturing, regulatory compliance, engineering, etc.

• Direct experience leading and developing teams in a highly regulated industry.

Preferred:

• Applied understanding of QMSR (21 CFR Part 820), ISO 13485, and other relevant QMS regulations.

• Proven ability to work effectively with various work groups and multinational teams.

• Demonstrated ability to drive consensus cross functionally for strategy.

• Strong interpersonal and stakeholder management skills, with experience engaging across all levels of a global organization.

• Strong communication, project management and influencing skills, with a demonstrated ability to manage multiple priorities.