Stryker Corporation

Staff Quality Systems Specialist

Stryker Corporation • $91K — $152K *
Cary, IL 60013In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Science, Engineering, Business, Quality, or related field.
  • Minimum of 4 years supporting Quality Systems in regulated industries.
  • Experience in developing and improving Quality Management Systems (QMS).
  • Strong working knowledge of document control, change management, and risk management processes.
  • Proven ability to identify and resolve quality compliance risks.

Responsibilities

  • Ensure compliance with regulatory and quality standards such as FDA and ISO 13485.
  • Lead and enhance Quality Systems to meet business and regulatory needs.
  • Act as a subject matter expert for assigned QMS processes.
  • Identify and implement process improvements to boost Quality System efficiency.
  • Maintain and improve quality documentation and procedures.
  • Manage Quality Systems initiatives and cross-functional projects.
  • Support audits, inspections, and certification activities effectively.

Benefits

  • Hybrid work flexibility.
  • Opportunity to work in a regulated industry with a focus on quality and compliance.
  • Involvement in cross-functional collaboration and project management.
  • Potential for robust professional development in Quality Systems.
  • Access to training initiatives focused on best practices in quality management.
Full Job Description
Work Flexibility: Hybrid

The Quality Systems Specialist will oversee, support, and ensure that an effective and efficient quality management system is built and maintained. Responsibility for ensuring that all applicable quality system regulations are met to receive regulatory clearance/certification.

What you will do:
  • Ensure compliance with applicable regulatory and quality standards, including FDA, ISO 13485, MDR, GMP, GDP, and corporate requirements.
  • Lead the development, implementation, and continuous improvement of Quality Systems to support business objectives and regulatory compliance.
  • Serve as a subject matter expert and process owner for assigned Quality Management System (QMS) processes.
  • Identify, evaluate, and implement process improvements to enhance Quality System effectiveness, efficiency, and inspection readiness.
  • Develop, maintain, and improve quality policies, procedures, and documentation to support operational and regulatory requirements.
  • Lead Quality Systems initiatives and cross-functional projects, applying project management principles to achieve key milestones and deliverables.
  • Support internal and external audits, regulatory inspections, and certification activities, including interactions with notified bodies and audit response activities.
  • Develop and deliver training, provide guidance to stakeholders, and promote Quality Systems best practices across the organization.


What you need:

Required:
  • Bachelor's degree in Science, Engineering, Business, Quality, or a related discipline.
  • Minimum of 4 years of experience supporting Quality Systems within a regulated industry (e.g., medical device, pharmaceutical, biotechnology, cosmetics, manufacturing, aerospace, or other regulated environments).
  • Experience developing, implementing, maintaining, and/or continuously improving Quality Management System (QMS) processes, procedures, and documentation.
  • Working knowledge of core Quality Systems elements such as document control, change management, risk management, validation, or design controls.
  • Experience supporting compliance activities, identifying quality or compliance risks, and driving appropriate documentation, escalation, and resolution.

Preferred:
  • Experience participating in Quality System integration, harmonization, merger, acquisition, or transformation initiatives across sites, business units, or organizations.
  • Strong technical writing and documentation experience, including development or standardization of procedures, work instructions, quality records, validation documentation, or integration plans.


$91,600 - $152,700 USD Annual

Travel Percentage: 10%

About Stryker Corporation

Stryker Networks is a premier Information Technology partner providing IT managed services and database application development.

Stryker Corporation Careers

Joining Stryker Corporation means becoming part of a global team recognized for its commitment to innovation, leadership, and enhancing patient outcomes. As a leading medical technology company, Stryker is the perfect place to build a career that truly makes a difference.

Work You’ll Do

At Stryker, every position contributes to our mission of making healthcare better. Here, you will use your skills to work on transformative projects that improve lives across the globe. You will be part of a culture that thrives on growth, innovation, and leadership, and you will work alongside some of the brightest minds in the industry.

Innovative Careers

Stryker offers a range of job opportunities, from internships that provide a stepping stone into high-impact roles to leadership positions that drive strategic direction. Our team members benefit from a work environment that supports professional growth and diversity training, ensuring everyone, regardless of background, can thrive.

Be Part of a Great Team

Our employees enjoy a collaborative atmosphere that fosters innovation and encourages professional development. With a commitment to leadership and diversity, Stryker ensures that all team members have the opportunity to grow and influence the company's future. Our global scale and dedication to impactful solutions make us leaders in medical technology.

Future-Proof Your Career

Stryker is dedicated to career development, offering extensive training, benefits, and resources to help you advance professionally. From networking opportunities to workshops on resume and interview skills, we support your journey every step of the way. Our career paths are as diverse as the innovative products we develop and the markets we serve.

Explore Job Opportunities

Whether you’re just starting out or looking to take your career to the next level, Stryker provides the tools and resources to achieve your goals. We are continuously hiring and looking for ambitious, curious, and driven individuals to join our team.

Stryker Corporation – A Leader in Medical Technology

Our commitment to improving healthcare through innovative products sets us apart in the medical technology field. The synergy of our team’s expertise and our leadership in technology solutions enables us to meet the needs of our customers effectively.

Stay Connected

Join Our Team Search open positions that match your skills and interest. We look for passionate, creative, and solution-driven team players. Explore the many benefits of employment at Stryker, a company that values innovation and leadership.

Keep Up to Date

Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here.

Job Alert Emails

Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities that await at Stryker Corporation.

Stryker Corporation – Where Talent Meets Opportunity

At Stryker, we believe in turning the challenges of today into the breakthroughs of tomorrow. Join us in our mission to improve healthcare around the world.
Learn more about Stryker Corporation
Size
46,000 employees
Market Cap
$91.9 billion
Industry
Healthcare
Net Income
$1.5 billion
Founded
2004
5 Year Trend
+8.6%
Revenue
$14.3 billion
NASDAQ
SYK
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Stryker Corporation

More Pharmaceuticals & Biotech Jobs

Find similar Staff Quality Systems Specialist jobs:

NationwideCary, IL