Senior Quality Systems Specialist

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

Benefits offered by this job

Hybrid work model

Job summary

Stryker in Redmond, WA is seeking a Senior Quality Systems Specialist to drive the quality management system, lead CAPA and NC processes, and partner with cross-functional teams to resolve issues and ensure regulatory compliance in a hybrid work setting.

The role requires a Bachelor's in Science or Engineering and 3+ years in manufacturing, with strong communication and project management skills, experience with CAPA, quality systems, and audits. Some travel may be required.

Qualifications

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

Responsibilities

• Own and oversee NC and CAPA processes to ensure compliance, effectiveness, and efficiency.
• Review and approve NCs and CAPAs for completeness and timeliness.
• Partner with cross-functional teams to facilitate investigations and root-cause analyses.
• Serve as site SME and super user for the eCAPA system with proper records.
• Coach teams on problem-solving methods (5 Whys, Fishbone, Process Mapping, 4-D).
• Lead CAPA review boards and RCA workshops to drive quality improvements.
• Monitor and report NC/CAPA KPIs for governance forums.
• Develop and deliver training programs on CAPA processes and quality systems.
• Identify and implement continuous improvement initiatives to optimize quality systems.
• Participate in cross-site and corporate quality improvement projects.
• Support audits with preparation, participation, and follow-up.

Skills

Quality systems

CAPA

Project management

Cross-functional collaboration

Education

Bachelor's degree in Science or Engineering

Tools

eCAPA system

MS Office

Job description

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

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