Quality System Specialist

Stryker; Redmond (WA); Hybrid; USD 77.000 - 117.000; Vollzeit

Zusammenfassung

Stryker is seeking a Quality System Specialist in Redmond, WA. The role focuses on developing and maintaining the quality management system to meet regulatory requirements for medical devices.

It is a hybrid position in Redmond, Washington, supporting QMS and regulatory activities. Qualifications include a science/engineering degree with 0-2 years in manufacturing or related fields, familiarity with FDA/ISO requirements, strong communication, and the ability to work independently.

Qualifikationen

• Bachelor’s Degree in a science, engineering or related discipline or equivalent experience.
• 0-2 years experience in manufacturing environment or equivalent.
• Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.).
• Knowledge of US, European and international regulatory guidelines/standards.
• Strong communication, project management and influencing skills; ability to manage multiple tasks.

Aufgaben

• Support QMS compliance with internal and external regulatory requirements.
• Manage documents and document changes within the electronic documentation system.
• Facilitate engineering documentation management including DMR, DHF and technical standards.
• Perform change control/configuration management checks for compliance with local procedures.
• Administer and maintain the electronic document management system with user access and training records.
• Coordinate internal and external audits and support GMP/GDP within Quality organization.

Kenntnisse

Communication

Project management

Influencing

Analytical thinking

Ausbildung

Bachelor's degree in science/engineering or related discipline

Tools

Microsoft Word

Excel

PowerPoint

Jobbeschreibung

Work Flexibility: Hybrid

As the Quality System Specialist you will support the development of the quality management system in accordance with relevant regulatory requirements for medical devices. Oversee, support, and ensure that an effective and efficient quality management system is built and maintained. Responsibility for ensuring that all applicable quality system regulations are met in order to receive regulatory clearance/certification. This role is Hybrid in Redmond, Washington.

What you will do

Support QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, ISO, MDD, and individual country requirements). Manage documents and document changes throughout QMS document lifecycle within electronic documentation system Facilitate engineering documentation management within electronic documentation system including DMR, DHF and technical standards. Perform change control/configuration management checks to engineering documentation to ensure compliance with local procedures Administer and maintain the electronic document management system, ensuring user access, permissions, and training records remain current. Perform document control checks to ensure documents and document changes comply with local procedures. Provide guidance to process owners, document creators, document reviewers and document approvers on the overall process and electronic management system. Identify improvements and inputs into the quality planning process Execute development and/or modifications of Stryker’s QMS Support Management Review and Quality Planning Review and related forums. Support GMP and GDP within Quality organization. Support QMS training development and delivery. Support implementation of best-in-class practices and benchmark against industry leaders and regulatory requirements. Support notified body communication. Ensure QMS reflects actual activities, business needs and supports NPD requirement. Coordinate internal and external audits, including securing conference rooms, communicating with SPOs/SMEs, and coordinating front room/back room logistics. Support internal and external audits by providing documentation and ensuring records are complete, accurate, and retrievable.

What you need

Bachelor’s Degree in a science, engineering or related discipline, or equivalent experience 0-2 years experience in manufacturing environment or equivalent. Preferred Minimum of 2 years experience in area of quality systems, engineering, or equivalent experience preferred. Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) Demonstrated knowledge of U.S., European, and international regulatory industry guidelines/standards and ability to interpret and apply. Knowledge and understanding of U.S. and International medical device regulations. Knowledge of supporting Quality Systems (audits, management review, quality planning, etc.) Strong communication, project management and influencing skills and have the ability to manage multiple tasks simultaneously. Strong written and oral communication and negotiation skills. Strong critical thinking skills. Developed problem-solving skills. Strong analytical skills. Demonstrated ability to successfully manage and complete projects in a matrix organization. Demonstrated ability to work independently. Experience working in a compliance-risk situation. Computer literacy, including Microsoft Word, Excel and PowerPoint. Some travel may be required.

United States of America Pay Ranges

US15: $76,500 - $117,100 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 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.