Senior Quality Systems Specialist

Stryker; Redmond; Hybrid; AUD 119,000 - 198,000; Full time

Benefits offered by this job

Hybrid work model

Health benefits

Job summary

Stryker in Redmond, WA is seeking a Senior Quality Systems Specialist to drive CAPA/NC processes, partner with cross-functional teams, and serve as the site expert for the eCAPA system. This role emphasizes quality excellence, regulatory compliance, and continuous improvement across the organization.

The position requires a Bachelor’s degree in Science or Engineering and 3+ years in manufacturing or similar settings, with strong communication and project management skills.

Qualifications

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

Responsibilities

• 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.

Skills

Strong communication

Project management

Cross-functional collaboration

Analytical thinking

Problem-solving

Education

Bachelor’s degree in Science/Engineering or related

Tools

Microsoft 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

View the U.S. work location and transparency guide to find the pay range for your location.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.