Hollister Incorporated en
Alliance for Recruitment is the largest recruitment consultancy in Lithuania measured by capacity, number of successful placements and annual growth. We are a high performing team of recruitment experts from various different industries.
Our client – Hollister Lietuva is a part of Hollister Incorporated that is an independent, employee-owned company that develops, manufactures, and markets healthcare products and services worldwide. They offer advanced medical products for Ostomy Care, which includes strong global brands – Hollister Ostomy and Dansac Ostomy; Continence Care; Critical Care; and Wound Care. They also provide innovative healthcare programs and services, as well as educational materials for patients and healthcare professionals. Hollister has been serving healthcare professionals and patients for 100 years — making a difference in the journey of life for people throughout the global community.
As the company is expanding, we are looking for a person to join the Quality Assurance Manager position. Provide leadership and vision for the deployment of a sound Quality Management System (QMS) that complies with regulatory requirements compatible with Hollister’s Mission and Vision.
• Develop and advise on the development of QMS and procedures.
• Collaborate with manufacturing to ensure achievement of existing quality levels of manufactured products and seek methods to continually improve quality and reduce customer complaints.
• Provide leadership in change management and risk assessment.
• Provide input to the Global Quality Management (GQM) strategic plan as required.
• Provide direct leadership to the overall plant operations as a member of the plant leadership team.
• Develop and maintain a plan for the professional development and coaching of all direct reports.
• Provide project leadership for implementing continuous Quality improvement projects.
• Oversee customer complaints, nonconformities and CAPA handling
• Advise and participate in IT solutions for quality system improvements.
• Participate in quality planning and governance activities with domestic and foreign suppliers.
• Oversee resources for product verification, validation, investigation and releasing finished goods into distribution.
• Ensure trainings and awareness in QMS and regulatory requirements among all employees.
• Perform the duties of a Management Representative as required
• Act as key liaison with all regulatory agencies including FDA and ISO.
• Act as Person Responsible for Regulatory Compliance to ensure conformity of the medical devices is checked in accordance with Quality Management System (procedures/specifications).
• Other duties and tasks as assigned.
Specialized Skills/Technical Knowledge:
• Supervisory experience required with excellent independent judgment skills.
• Project Management skills required.
• Good technical writing skills and attention to detail.
• Knowledge of quality engineering tools and statistical quality control techniques.?
• Knowledge of applicable foreign and domestic regulations.
• Knowledge of quality auditing techniques in FDA/ISO regulated environment preferred.
• Knowledge of process validation techniques.
• Basic knowledge of sterilization.
• Knowledge of Good Manufacturing Practices, ISO 13485 and FDA CFR Part 820.
• Greenbelt certification preferred with knowledge of Lean and Six Sigma methodologies required.
• Knowledge of SAP/ERP Systems preferred.
• English and Lithuanian language required.
• Bachelor’s Degree.
4500 EUR/Gross – 5200 EUR/Gross + benefits.