Job Description

Work Flexibility: Hybrid or OnsiteStryker is seeking to hire a Staff Quality Systems Specialist - Continuous Improvement in Cary, IL. As a Staff Quality Systems Specialist, you will be primarily responsible for the development of the quality management system (QMS) in accordance with relevant regulatory requirements. Oversee, support, and ensure that an effective and efficient QMS is built and maintained. Responsibility for ensuring that all applicable quality system regulations are met to receive regulatory clearance/certification. Facilitates proactive and effective resolution of issues through expertise in problem-solving methodology.Workplace Flexibility: Hybrid work schedule with three onsite days (Monday, Tuesday, and Wednesday) and the option to work remotely on Thursday and Friday. Candidates must reside within a reasonable commuting distance of Cary, IL to support regular onsite collaboration and business needs.What you will do:Support the maintenance, compliance, and continuous improvement of the Quality Management System (QMS) to ensure alignment with internal procedures, regulatory requirements, and business objectives.Identify, recommend, and implement process improvements that enhance the effectiveness, efficiency, and scalability of quality system processes.Partner cross-functionally to develop, revise, and maintain quality system policies, procedures, and documentation that support operational and new product development activities.Coordinate QMS activities and quality initiatives to support business priorities, project milestones, and organizational objectives.Monitor and analyze quality system metrics, key performance indicators (KPIs), and process performance data to identify improvement opportunities and drive action plans.Provide training, guidance, and subject matter expertise on QMS processes, compliance requirements, and quality best practices.Support internal, corporate, and external audit activities, including audit preparation, participation, response coordination, and follow-up actions.Promote compliance with applicable quality standards and regulations, including FDA, ISO 13485, MDR, GMP, GDP, and other relevant requirements.What you will need:Required:Bachelor’s Degree in a Science, engineering, business or related disciplineMinimum of 4 years of experience supporting Quality Systems within a regulated industry (e.g., medical device, pharmaceutical, biotechnology, cosmetics, manufacturing, aerospace, or other regulated environments).Experience developing, implementing, maintaining, and/or continuously improving Quality Management System (QMS) processes, procedures, and documentation.Working knowledge of core Quality Systems elements such as document control, change management, risk management, validation, and/or Corrective Action Preventative Actions (CAPA) .Preferred:Proficiency in statistical analysis methods and the application of data-driven decision-making tools.Experience utilizing structured problem-solving and continuous improvement methodologies (e.g., process mapping, benchmarking, root cause analysis, fishbone diagrams, tree diagrams).Demonstrated experience identifying process improvement opportunities and leading initiatives from assessment through implementation.Experience driving operational, quality, or compliance-related efficiency improvements within a regulated environment.$91,600 - $152,700 USD AnnualTravel Percentage: 10%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.SummaryLocation: Cary, IllinoisType: Full time

Job Tags

Similar Jobs