Senior Quality Systems Specialist

Stryker•Redmond, WA

4d•Hybrid

About The Position

As a Senior Quality Systems Specialist, you will help ensure 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. The role offers the opportunity to influence quality excellence, continuous improvement, and regulatory compliance across the organization. It is hybrid and based in Redmond, Washington.

Requirements

Bachelor’s degree in Science, Engineering, or a related discipline.
Minimum of 3 years of experience in a manufacturing environment or equivalent.
Strong communication, project management, and influencing skills.
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.

Nice To Haves

At least 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.

Responsibilities

Own and oversee 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 contain 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.