Senior Quality Systems Specialist

Stryker; Redmond (WA); Hybrid; USD 83,000 - 139,000; Full time

Job summary

Stryker Corporation in Redmond, WA is seeking a Senior Quality Systems Specialist to drive NC and CAPA processes within a hybrid work model. You will lead investigations, perform root cause analysis, and ensure timely CAPA execution across cross-functional teams.

The role requires a Bachelor’s in Science or Engineering, 3+ years in manufacturing, strong analytical and regulatory know-how, and the ability to coach teams in problem-solving. Travel may be required.

Qualifications

• Bachelor’s degree in Science, Engineering, or a related discipline.
• Minimum 3+ years of experience in a manufacturing environment or equivalent.
• Strong analytical, critical thinking, and problem-solving capabilities.
• Experience interacting with regulatory agencies such as FDA, TUV, and other international regulatory bodies.
• Knowledge of U.S., European, and international medical device regulations and standards.
• Willingness to travel as needed.

Responsibilities

• Own and oversee the NC and CAPA processes to ensure compliance, effectiveness, and efficiency in addressing quality issues.
• Review and approve NCs and CAPAs for completeness, accuracy, effectiveness, and timeliness.
• Partner with cross-functional teams to facilitate investigations, root cause analysis, and corrective action implementation.
• Serve as the site subject matter expert and super user for the eCAPA system, ensuring records are maintained with appropriate supporting evidence.
• Coach and mentor teams on problem-solving methodologies, including 5 Whys, Fishbone Diagrams, Process Mapping, Human Error Reduction, and 4-D methodologies.
• Lead accountability meetings, CAPA review boards, and root cause analysis workshops to drive quality improvements.
• Monitor and report NC/CAPA key performance indicators (KPIs), providing updates for quality and business review forums.
• Develop, maintain, and deliver training programs related to CAPA processes and quality systems.
• Identify and implement continuous improvement initiatives to optimize quality systems and business processes.
• Participate in cross-site and corporate quality system improvement projects.
• Support internal, corporate, customer, and third-party audits, including preparation, participation, and follow-up activities.

Skills

Strong communication

Project management

Influencing skills

Independent work

Education

Bachelor’s degree in Science/Engineering

Tools

Microsoft Office

Job description

Work Flexibility: Hybrid As a Senior Quality Systems Specialist, you will play a critical role in ensuring the effectiveness of Stryker's quality management system by driving compliance, leading problem-solving efforts, and partnering with cross-functional teams to resolve quality issues. This position offers the opportunity to influence quality excellence, continuous improvement, and regulatory compliance across the organization. This role is Hybrid in Redmond, Washington.

What You Will Do

• Own and oversee the Nonconformance (NC) and Corrective and Preventive Action (CAPA) processes to ensure compliance, effectiveness, and efficiency in addressing quality issues.
• Review and approve NCs and CAPAs for completeness, accuracy, effectiveness, and timeliness.
• Partner with cross-functional teams to facilitate investigations, root cause analysis, and corrective action implementation.
• Serve as the site subject matter expert and super user for the eCAPA system, ensuring records are maintained with appropriate supporting evidence..
• Coach and mentor teams on problem-solving methodologies, including 5 Whys, Fishbone Diagrams, Process Mapping, Human Error Reduction, and 4-D methodologies.
• Lead accountability meetings, CAPA review boards, and root cause analysis workshops to drive quality improvements.
• Monitor and report NC/CAPA key performance indicators (KPIs), providing updates for quality and business review forums.
• Develop, maintain, and deliver training programs related to CAPA processes and quality systems.
• Identify and implement continuous improvement initiatives to optimize quality systems and business processes.
• Participate in cross-site and corporate quality system improvement projects.
• Support internal, corporate, customer, and third-party audits, including preparation, participation, and follow-up activities.

What You Need

• Bachelor’s degree in Science, Engineering, or a related discipline.
• Minimum 3+ years of experience in a manufacturing environment or equivalent.
• Strong communication, project management, and influencing skills.
• Demonstrated ability to manage multiple priorities in a fast-paced, matrixed environment.
• Strong analytical, critical thinking, and problem-solving capabilities.
• Ability to work independently and drive issues to resolution.
• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.
• Preferred 2+ years of experience in CAPA, Quality Systems, Quality Engineering, or a related field.
• Experience interacting with regulatory agencies such as FDA, TUV, and other international regulatory bodies.
• Knowledge of U.S., European, and international medical device regulations and standards.
• Strong understanding of quality system processes, including audits, management review, and quality planning.
• Experience working in compliance-risk environments.
• Demonstrated success leading projects and driving results across cross-functional teams.
• Excellent written, verbal, and negotiation skills.
• Ability to facilitate teams through complex investigations and root cause analyses.
• Experience supporting multi-site or global quality initiatives.
• Willingness to travel as needed.

United States of America Pay Ranges: US15: $83,400 - $139,000 USD Annual View the U.S. work location and transparency guide to find the pay range for your location.

Travel Percentage: None

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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

We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility Options

• Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location.
• Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.
• Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category.
• Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.