Quality Manager

2 days ago

Ljubljana, Ljubljana, Slovenia STERIS Full time

Position summary

The Quality Manager is responsible for leading quality improvement for a manufacturing or service

facility/function. This position leads implementing and maintaining state-of-the-art quality

practices for associated product and service lines. The Quality Manager assumes overall

responsibility in ensuring that the site maintains operational and quality systems in a state of

compliance to domestic and international standards. The role is responsible for the organization,

documentation and maintenance of the quality system to be compliant with, as appropriate, the

following standards: IS0 9001, ISO 13485, MDSAP and CFR Part 820/211, EU MDR and other

applicable standards. This role leads the local site efforts focused on product/service quality

improvement, supplier quality, process quality, new product/service development quality and

quality system compliance. The Quality Manager serves as the Management Representative for

the site(s) and is responsible for ensuring the quality system meets all applicable regulatory

standards.

Duties

  • Lead the organization's Quality staff to ensure compliance to the overall Quality Management System and drive continuous improvement. 
  • Lead the organization's Quality staff to ensure alignment to manufacturing and servicing operations, support Lean efforts and drive quality improvement for products and services.
  • Work closely with site senior management to provide strategic direction and development of the organization's quality strategies and tactics.
  • Provide quality viewpoints and opinions on future product and service development.
  • Provide coaching, mentoring and leadership to the Quality staff.
  • Serve as the site's Management Representative and lead the organization's Management Review process.
  • Ensure compliance with appropriate domestic regulatory and international standards and requirements.
  • Lead the organization's continuous improvement process; including data analysis, improvement projects and process capability to improve key metrics as measured by the product/service quality dashboard.
  • Lead and implement effective production and process controls.
  • Manage the complaint handling processes to insure customer responsiveness and product and process improvements.
  • Ensure compliance to the New Product Development process and assurance that the Product Requirements Document includes key quality performance metrics.
  • Assess new designs for manufacturability, testability and reliability to ensure the Quality risks and deliverables of the New Product Development process meet the required application reliability and design intent.
  • Determine supplier qualification risks based upon criticality of component and supplier process capability.
  • The position requires a level of authority to conduct and direct required activities such as quality planning, personnel management and regulatory compliance.
  • This individual has autonomy to perform the duties of Person Responsible for Regulatory Compliance (PRRC) on behalf of STERIS legal manufacturing entities under the EU MDR.
  • This individual shall suffer no disadvantage within the organization in relation to proper fulfilment of his or her duties in lieu of article 15 of the EU MDR.

Education & Experience

Bachelor's Degree in Engineering or a related technical field (higher degrees and professional certifications are a plus).
8–12 years of combined experience in Manufacturing/Quality Engineering and/or Quality Systems.
8–12 years of experience in medical device or other regulated industries preferred.
8–12 years working in an ISO certified environment required.
Minimum 2 years in a Quality leadership role.
Must meet experience requirements listed in Article 15 of the EU MDR (PRRC).
ASQ, QSR, or familiarity with QSR/GMP regulations preferred.

Skills & Competencies

Excellent problem-solving skills.
Strong focus on identifying potential issues and driving continuous improvement.
Experience working on cross-functional teams and independently.
Outstanding organizational, oral, and written communication skills.
Proficient in desktop applications (Excel, Word, PowerPoint); experience with statistical analysis software and Visio preferred.

Working Conditions

Domestic travel required (10–20% of time).
Typical office setting, with possible work in manufacturing/operations centers and laboratories.
Physical activities similar to office environment.

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