Quality Engineer

Why engineering at Stryker?

At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.

Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-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

Stryker is hiring a Quality Engineer in Mahwah, New Jersey, to support Joint Replacement! In this role, you will be responsible for providing quality engineering support in quality assurance, control and preventative activities within operations and other business functions. There will be a focus on preventative measures and continuous improvement of products and processes. You will advocate and lead the execution of initiatives & projects to enhance quality performance within the business and ensure compliance to regulation and standards.

Who we want

• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
• 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

• Will work within the quality operations team, with moderate supervision and mentoring, with responsibility for quality-related activities, including, but not limited to the following:
• Work closely with operations and the business functions to ensure quality performance of products and processes.
• Initiation and ownership of NC and CAPA, builds proficiency in problem-solving and root-causing activities.
• Participate in the development and improvement of the manufacturing processes for existing and new products.
• Review of change management activities.
• Maintain KPIs for monitoring of process and supplier quality, perform analysis and interpret trends, and take action as necessary.
• Support execution and analysis of QATs.
• Advocate of Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.
• Develop an understanding of risk management practices and concepts and become proficient in process risk.
• Develop an understanding of optimization of inspection methods and sampling. Support First Article Inspections.
• Develop proficiency in statistical methods and application.
• Develop an understanding of manufacturing prints and tolerancing.
• Builds strong relationships by fostering open communications, respect, and trust. Strong team player and acts with a customer service/stakeholder-focused approach
• Is diplomatic, tactful, and leverages excellent interpersonal keys to help achieve outcomes.

What you need

Required:

• Bachelor’s Degree in engineering required. Biomedical Engineering, Mechanical Engineering, or related discipline preferred.
• 0+ years of related experience

Preferred:

• 1+ years of experience in Med Device preferred.
• Understanding of Med Device concepts highly desirable.
• Familiarity with ISO 13485, GDP, GMP concept highly desirable.
• Excellent communication skills and attention to detail.
• You should have a good understanding of engineering and quality concepts / theories.
• High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
• Self-starter with efficient work style and ability to handle multiple tasks in a fast-paced environment.
• You should be willing to work as part of a multi-site team.
• Knowledge of Risk Based and statistical concepts desirable.
• Problem solving and analytical skills.
• You should be able to build strong relationships by fostering open communications, respect, and trust. Strong team player and acts with a customer service/stakeholder focused approach.
• Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes.
• Accepts change openly and adopts a continuous improvement orientation to the role.
• Ability to be the voice of Quality when dealing cross functionally.

About Stryker

Our benefits:

• 12 paid holidays annually
• Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
• Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits

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.

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program on our referral page

Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.