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We Make Life More Rewarding and Dignified

Location: Kaunas

Department: Quality

Summary:

The position will provide QA leadership for the QA testing laboratory & QA specialists.

The main responsibility of he role will be to ensure continued compliance of the Quality Management System according to the relevant regulatory requirements as well as ensuring the Kaunas plant meet product (device) requirements.

As a QA leader they will strive for a dynamic Culture of Quality to continuously improve our products, processes and Quality Management System (QMS) to best fulfil our Mission and Vision.

Responsibilities:

• Lead and develop Quality Team by developing and maintaining a plan for the professional development and coaching of all direct reports
• Implement QMS and procedures within the plant and support of global quality procedures - in line with regulatory requirements.
• Provide resources for maintaining, archiving and control of the documents and records.
• Provide resources for validation testing, maintenance and calibration of test equipment.
• Participate in development of culture of compliance to good manufacturing practices. This includes support in development and delivering ongoing trainings.
• Provide QA technical direction and guidance to achieve company objectives
• Collaborate with Manufacturing & Plant Quality Assurance Manager(s) to ensure achievement of existing quality levels of manufactured products and seek methods to continually improve quality outcomes including leading on cost of quality and Culture of Quality initiatives
• Collaborate with Value Stream to identify, investigate and solve quality issues
• Act as a lead auditor, create and coordinate the Internal audit program.
• Coordinate the CAPA program.
• Identify and initiate CAPA's as needed to drive improvements. Respond to assigned CAPAs for investigation, root cause analysis and implement solutions.
• Ensure team is trained to FDA QSR, ISO 13485, MDSAP and EU MDR requirements.
• Participate in external audits.
• Provide Quality metric reporting.
• Serve as back-up to QA Manager for Compliance area, as required.
• Other duties and tasks as assigned.

Essential Functions of the Role:

• Build and deliver effective communications at all levels while displaying active listening skills.
• Good interpersonal skills with the ability to work as part of a cross functional team.
• Prolonged periods of sitting and standing.
• Ability to interface with a computer for a long period of time.
• Frequent movement over large manufacturing floor area.
• Good Communication skills, both written and oral.
• Constant utilization of speaking and listening skills, both person to person and over the phone.

Work Experience Requirements

• Number of

Overall Years Necessary: 5-8

• Minimum of 2-3 years experience in an ISO and /or FDA Regulated industry in Quality Engineering/ Assurance role.
• Bachelor's Degree in Physical Science, Engineering or other related discipline
• Master's Degree is preferred.

Specialized Skills/Technical Knowledge:

• Supervisory experience required with excellent independent judgement skills.
• Project Management skills preferred
• Good technical writing skills and attention to detail.
• Knowledge of applicable foreign and domestic regulations.
• Knowledge of quality auditing techniques in FDA/ISO regulated environment preferred.
• Knowledge of Good Manufacturing Practices, ISO 13485 and FDA CFR Part 820.
• Greenbelt certification preferred with knowledge of Lean and Six Sigma methodologies preferred. Or Good working knowledge of continuous improvement and root cause problem solving in a manufacturing setting
• Knowledge of SAP/ERP Systems preferred
• Proficient computer skills, including Microsoft Office Suite (Word, PowerPoint, Project, Access), especially Excel.

Local Specifications (English and Local Language):

• English and Lithuanian language required

Salary

euros gross.

About Hollister Incorporated

Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide.

The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals.

Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries.

Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.

Hollister is an EO employer - M/F/Veteran/Disability

Job Req ID: 32963

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