Associate Manager, Quality Systems
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What you'll 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 they're looking for
- 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.
Nice to have
- 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.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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%
Company
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