Senior Manager, Quality Assurance

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

PositionSummary

 Establish a quality centre of excellence, develop organisational strategies, processes, goals, and metrics to drive measurable improvements in quality processes. Oversee the consistency of quality processes. Manage and address potential product and safety investigations through investigation and corrective action. 

KeyAreasofResponsibility

• Manage day-to-day quality processes to ensure issues are appropriately evaluated 

• Establish annual budgets and quarterly forecasts. Make necessary changes with appropriate management involvement 

• Communicate and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are met 

• Develop teams to ensure timely resolution of inprocess and supplier product technical issues to avoid disruption and ensure continuity of supply

• Serve as a site leader for GQO quality processes 

• Provide guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations 

• Establish standard process to ensure appropriate resolution and management of the responsible task owner 

• Chair meetings required to drive closure of quality issues 

• Manage and provide updates for quality metrics. Implement appropriate enhancements 

• Represent quality processes during internal and external audits 

• Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets 

• Recruit, select, and on-board top talent 

• Develop talent within team to increase performance. Actively address performance issues on team 

• Maintain a high level of team engagement 

QualificationsKnowledgeSkills

• Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements 

• Demonstrate technical knowledge of medical device product lines 

• 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 process improvement and management skills 

• Experience with recruiting, people development 

• Influence across the organization

• Demonstrate an entrepreneurial spirit for driving business forward- relentless drive to deliver on bold and innovative change initiatives 

• Increases business impact by holding self and others accountable for collaborating with global colleagues across functions and divisions, internally and externally 

• A predisposition for coaching and mentoring and a genuine interest in helping others develop 

• Strong emotional intelligence to guide how to achieve through others 

• Exceptional communication skills to influence key decision makers at all levels within the Organisation 

• Great interpersonal skills- a Team player 

• A strong leader with a skill for engaging their team in a common goal 

• Service minded and courageous 

Preferred: 

• BS in a science, engineering or related Advanced degree preferred 

• Minimum of 10 years experience, 7 years of supervisory experience preferred 

• Masters Degree or equivalent preferred 

• Experience working in a regulated environment 

• Good understanding of manufacturing process technologies, and the ability to understand complex processes 

• Experience with delivering results through 6 sigma and lean methods 

• Strong analytical ability, relevant ERP knowledge (preferably SAP, Oracle or JDEdwards) and experience and strong PC skills (MS Excel, Access, etc.,) 

About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.