Senior Quality Systems Specialist

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

Job summary

Stryker in Redmond, Washington is seeking a Senior Quality Systems Specialist to drive CAPA/NC (nonconformance) processes, ensure the effectiveness of the quality management system, and partner with cross-functional teams to resolve quality issues.

In this hybrid role, you will lead investigations, mentor teams on problem-solving methods, and support audits while advancing continuous quality improvements across the organization.

Qualifications

• Bachelor's degree in Science, Engineering or 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.

Responsibilities

• Own and oversee NC and CAPA processes to ensure compliance, effectiveness and efficiency.
• 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 SME and super user for the eCAPA system with proper supporting evidence.
• Coach and mentor teams on problem-solving methodologies like 5 Whys, Fishbone, Process Mapping, and 4-D.
• Lead accountability meetings, CAPA review boards, and root cause analysis workshops.
• Monitor and report NC/CAPA KPIs for quality and business reviews.
• Develop, maintain and deliver training on CAPA processes and quality systems.
• Identify and implement continuous improvement initiatives to optimize quality systems and processes.
• Participate in cross-site and corporate quality system improvement projects.
• Support audits, including preparation, participation and follow-up activities.

Skills

Communication skills

Project management

Problem solving

Analytical thinking

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.