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Stryker

Manufactures orthopedic and surgical medical devices

Senior Quality Engineer

Quality EngineeringConfirmed live in the last 24 hours
Full-timeSkawina, Poland

About the Job

Requirements

  • A Bachelor of Science degree in Engineering or a related subject and at least 2 years of work experience in a quality discipline are required.
  • A good understanding of engineering and quality practices and methods is required.
  • High-level knowledge or experience with risk-based and statistical techniques, particularly process risk, statistical sampling plans, process capability, and gauge repeatability and reproducibility, is required.
  • Experience validating processes is required.
  • Excellent written and spoken English and Polish are required.
  • The ability to represent Quality in cross-functional interactions and lead discussions and meetings to ensure the correct outcome is required.

Responsibilities

  • Partner with manufacturing and cross-functional teams to improve product and process quality performance and drive preventive quality activities.
  • Lead and support nonconformance and corrective/preventive action activities, including root cause analysis and implementation of effective corrective actions.
  • Drive continuous improvement initiatives by analyzing quality performance indicators and implementing actions to improve results.
  • Review, approve, and challenge change management activities to ensure robust quality and process effectiveness.
  • Lead quality-related activities for manufacturing process development, optimization, validation, and product transfers between facilities.
  • Apply risk management methodologies to identify process risks, evaluate mitigation strategies, and strengthen process controls.
  • Optimize inspection methods, statistical sampling plans, and process monitoring approaches to enhance quality assurance effectiveness.
  • Support and lead internal and external audits, including interactions with regulatory authorities, and provide quality expertise during inspections and reviews.

Desired Qualifications

  • Knowledge of ISO 13485, Good Manufacturing Practice (GMP), and Good Documentation Practice (GDP) requirements is advantageous.
  • Lean Six Sigma training is a distinct advantage.

About the Company

Stryker

Manufactures orthopedic and surgical medical devices

Stryker makes medical devices for hospitals, surgical centers and emergency responders, spanning joint implants, surgical instruments and patient transport equipment. Its Mako platform assists surgeons with joint replacement, while its neurotechnology products support brain and spine procedures and stroke treatment. Clinicians use its equipment during surgery and emergency care, and the company earns money by selling implants, disposable products and capital equipment through direct sales teams and distributors. The business also supplies training and technical support for healthcare providers using its devices. Stryker was founded in 1941 and is headquartered in Portage, Michigan.

Company size
10,001+
Company stage
IPO
Headquarters
Portage, MI
Founded
1941

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