Quality Assurance Manager – Stryker Orthopaedics Careers

Job Description:

Stryker is one of the leaders in the MedTech industry and we continue to grow and evolve. Stryker has expanded beyond being a Medical Device company. The former Sage Products location in Cary designs and manufactures products across the regulated spectrum (Medical Devices, Cosmetics and Pharmaceuticals). We are looking for a talented individual to join our team in Cary, Illinois.

Job Responsibilities:

• Provide SME input into quality planning process and assessment of risk
• Oversight of all aspects of projects assigned to quality engineering department including but not limited to establishment of clear objectives, planning and scheduling, data trending and analysis, cost assessment, training, implementation, reporting, etc.
• Identify and continually improve process effectiveness
• Facilitation of effective project meetings, change and conflict management
• Effective closure of quality investigations including CAPAs by mentoring and coaching investigation owners to ensure comprehension, development and execution of corrective/preventive action with regards to cited nonconformity
• Identify and communicate to quality leadership issues that impact product purity, quality, safety or efficacy, regulatory compliance or business continuity
• Procurement and assignment of Quality Engineering resources and general administration of the Quality Engineering department
• Leading cross functional project team(s) through variety of project types
• Monitoring of KPIs and process measures for the assigned area of management
• Development of resources planning estimates to manage project workload and productivity
• Ensure key site representation at external regulatory body audits

Job Requirements:

• Knowledge of FDA regulation 21CFR820 required, knowledge of 21CFR 211 preferred
• Knowledge of international standards and regulations as they pertain to Sage Products (i.e. MDD, ISO13485, EU GMPs, etc.)
• Managerial/supervisory strongly preferred
• Proficiency in using problem solving methods, root cause analysis and use of statistical tools to resolve problems
• Strong competencies in planning, project management, and organization with the ability to lead multiple activities and resources while maintaining a focus on quality
• Six Sigma or Project Management Professional certification is a plus

Qualification & Experience:

• Bachelor’s Degree in Engineering, Science or related technical field
• Experience managing complex or high-level projects
• Minimum 5 years’ experience in working in a highly regulated environment, quality, manufacturing or engineering
• Experience managing staff including administration and professional development
• Experience in quality management systems is essential

Job Details:

Company: Stryker

Vacancy Type:  Full Time

Job Location: Cary, IL, US

Application Deadline: N/A

Apply Here

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