Why RA/QA at Stryker?

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

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Our benefits include bonuses; healthcare; insurance benefits; retirement programs; stock based plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

Stryker is hiring a Staff Specialist, Quality Management Systems – Project Manager (remote, hybrid, or onsite) to support our Spine Division!

As a QMS expert, you will be responsible for leading projects that consist of evaluating and implementing new regulations, developing strategies, and implementing sizeable quality-driven business and compliance initiatives.

You will be responsible for the development of the quality management system in accordance with relevant regulatory requirements for medical devices. Oversee, support, and ensure an effective and efficient quality management system is built and maintained. Responsible for leading and directing moderate complexity projects as a QMS subject matter expert.

Work Flexibility: This role can be remote, hybrid, or onsite. It is preferable that you reside within a commutable distance of either Leesburg, VA, or Allendale, NJ.

Who we want:

• Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

What you will do:

• Ensure QMS compliance with the appropriate internal and external regulatory requirements and maintain awareness of the overall regulatory landscape.

• Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS.

• Develop optimum, future state of the QMS.

• Assess and quantify requirements for QMS requirements to optimize structure.

• Contribute to the development, maintenance, and improvements of policies and procedures.

• Implement best-in-class practices and benchmark against industry leaders and regulatory requirements.

• Drive GMP and GDP within RAQA organization

• Develop and deliver training for QMS areas of expertise.

• Communicate with notified bodies and health authorities.

• Represent expertise during internal and external audits for responsible processes and projects.

• Maintains strong knowledge of systems integration and interdependencies amongst the QMS.

• Provide direction for the overall QMS strategy.

• Lead improvement processes, including executing and leading projects.

• Responsible for assembling project teams, assigning individual responsibilities, identifying resource needs, and developing schedules to ensure timely project completion as a QMS expert with or without formal project management resources.

• Coordinate QMS activities to support the achievement of project milestones.

• Responsible for improving team performance by building team cohesiveness, leading, and motivating in order to facilitate cooperation, ensure project efficiency, and boost morale.

• Assist in developing best practices and benchmarking opportunities for the team and peer project managers.

What you need:

Required:

• Bachelor’s Degree is required.

• 4+ years of experience in the medical device industry with a focus on quality systems and / or regulatory affairs.

Preferred:

• Bachelor’s Degree with an emphasis in engineering, sciences, quality, or related discipline preferred.

• Quality and / or regulatory affairs certifications such as RAC, CQA, CQE, etc. are preferred.

• Thorough knowledge and understanding of US and international medical device regulations, including those of the EU and MDSAP regions.

• Strong knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)

• General understanding of global, device market authorization practices / processes.

• Knowledge of regulations, standards and industry practices associated with human and animal tissue is advantageous.

• Strong communication, project management and influencing skills.

• Excellent interpersonal, collaborative teamwork and negotiation skills.

• Must demonstrate the ability to effectively communicate up / down and across different levels of the organization and to build trusting relationships with mid-level management.

• Demonstrated ability to work in cross-functional team environments.

• Experience in compliance risk situations and analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.

Physical and Mental Requirements:

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Requirements listed here are representative of knowledge, skill, and / or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

$73,100 - $152,400 salary plus bonus eligible + Benefits (Health, Vision, Dental, 401K, Tuition Reimbursement, Employee Assistance Program, Wellbeing Program, Employee Stock Purchase Program). This information reflects the anticipated salary range for this position based on current national data. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.

The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.

More information is available at stryker.com