Staff Quality Systems Specialist Continuous Improvement

Stryker 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:

• Bachelors Degree in a Science engineering business or related discipline

• Minimum 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.

$91600 - $152700 USD Annual