- Temporary
- Full Time
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Why join Stryker?
Looking for a place that values your unique talents? Discover Stryker's award-winning culture.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
Job description
What you will do
Implementation and maintenance of QMS compliant with ISO 13485:2016.
Managing QMS documentation.
Managing CAPAs, non-conformances, complaints and other quality related activities.
Managing suppliers.
Lead internal audits.
Support external audits for ISO 13485:2016 certification.
Cooperating with operations and post market surveillance team.
Representing quality assurance and quality management within the business.
What you need
Required:
2–3 years of experience in the medical device industry
Knowledge of medical device quality management systems and regulatory compliance
English and Polish full professional proficiency
Knowledge of documentation lifecycle, risk assessment, and change management
Strong problem-solving abilities and experience in root cause analysis (RCA) and corrective action/preventive action (CAPA)
Preferred:
Certified Lead Auditor within ISO 13485:2016
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
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