Associate Manager, Quality Systems

Stryker Corporation; Skawina; On-site; Confidential; Full time

Job summary

Stryker Corporation in Poland is seeking an Associate Manager, Quality Systems to lead a team responsible for maintaining and improving quality processes, ensuring regulatory compliance, and driving operational excellence. You will coordinate audits, CAPAs, and document control while partnering across functions to mitigate risk and support sustainable growth.

The role requires a Bachelor’s degree or equivalent, at least 6 years in QA/Quality Systems or Regulatory affairs, and fluent English.

Qualifications

• Bachelor’s degree or equivalent.
• Minimum 6 years of experience in QA/Quality Systems/Regulatory.
• Experience with medical device quality and regulatory requirements (ISO 13485, FDA QSR).
• Experience supporting quality system processes (audits, reviews, documentation, CAPA, change control).
• Experience interacting with regulatory authorities and external auditors.
• Proven leadership in cross-functional, international environments; fluent English.

Responsibilities

• Lead and develop a team of Quality Systems professionals to meet quality and compliance goals.
• Manage quality system processes including CAPAs, document control, change management, and records.
• Ensure ongoing compliance with ISO 13485 and FDA QSRs across the organization.
• Coordinate internal/external audits and drive corrective action closure.
• Collaborate with cross-functional teams to address quality issues and reduce risk.
• Oversee nonconformances and maintain training programs and records.

Skills

Quality Systems

Team leadership

Audits

Regulatory knowledge

ISO 13485

Fluent English

Education

Bachelor's degree or equivalent

Tools

MS Office

Job description

Work Flexibility: Onsite Quality systems play a critical role in ensuring product quality, regulatory compliance, and patient safety. As Associate Manager, Quality Systems, you will lead a team responsible for maintaining and continuously improving quality processes while partnering across the organization to drive compliance, operational excellence, and sustainable business growth.

What You Will Do

• Lead and develop a team of Quality Systems professionals by setting clear objectives, providing coaching, and supporting career development to achieve quality and compliance goals.
• Manage quality system processes, including corrective and preventive actions, document control, change management, and quality records, ensuring compliance with applicable regulations and internal standards.
• Ensure ongoing compliance with global quality and regulatory requirements, including ISO 13485 and applicable FDA regulations.
• Coordinate and support internal and external audits, drive audit readiness activities, and ensure timely closure of audit observations and corrective actions.
• Partner with cross-functional teams to investigate quality issues, implement corrective and preventive actions, and reduce compliance risks.
• Oversee the documentation, review, investigation, and resolution of nonconformances in accordance with established procedures.
• Deliver and maintain quality systems training programs, ensuring training records and certifications remain current and compliant.
• Drive continuous improvement initiatives by monitoring quality system performance, analyzing trends, and implementing process enhancements that improve effectiveness and reduce risk.

What You Will Need

• Required Qualifications: Bachelor’s degree or equivalent.
• Minimum 6 years of experience in a Quality Assurance, Quality Systems, or Regulatory Affairs function.
• Experience working with medical device quality and regulatory requirements, including ISO 13485 and FDA quality system regulations.
• Experience supporting or managing quality system processes such as audits, management reviews, quality planning, document control, corrective and preventive actions, and change management.
• Experience interacting with regulatory authorities and external auditors.
• Experience leading and developing teams and working in a cross-functional, international environment.
• Fluent English (minimum B2 level), written and spoken.
• Advanced proficiency with standard business and computer applications.

Preferred Qualifications

• Master’s degree or PhD.
• Professional certifications such as Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Six Sigma certification.
• Knowledge of Medical Device Single Audit Program (MDSAP) requirements and other international medical device regulations.

Poland Pay Ranges: Poland, Skawina: 158.300 - 263.700 PLN gross annual

At Stryker, we believe transparency helps candidates make confident decisions about their next career step. Compensation is an important part of that process and we want to be clear about how pay is determined. The compensation information posted for this role may be presented as a salary range or a fixed amount depending on the role. In addition to base salary, this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable), along with Stryker’s comprehensive benefits package. If you’d like to learn more about the salary or the benefits associated with this role, your recruiter will be happy to walk you through the details as you progress through the hiring process.

Travel Percentage: 10%

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.