Quality Manager

For our client operating in the packaging industry,
we are looking for a Candidate for the position:

Main tasks:

• managing the Quality Division, responsible for Quality Control, Quality Assurance, Validation and Standards
• managing Quality Assurance System through designing internal processes that meet the system requirements, as well as introducing the appropriate KPIs and monitoring them
• contacting and collaborating other quality area or structures
• ensuring functioning of the ISO 13485, FSSC 22000 with accuracy and consistency
• keeping the ISO 13485, FSSC22000 systems in compliance with the applicable laws and quality standards, as well as ensuring their congruence with modifications and changes in legal acts, rules, and guidelines
• ensuring ongoing improvement of the ISO 13485, FSSC 22000 systems, optimising processes, documentation, and the appropriate transfer of information
• providing expertise and advice to the Management Board on GxP requirements and product quality matters
• expressing opinion, providing evaluations and endorsements for the ISO 13485, FSSC 22000 systems
• participating in projects/activities pertaining to investments, GxP improvements, optimising technological processes, new products implementation, other processes, and/or documentation
• initiating and building relationships with relevant institutions
• efficiently managing internal/external complaint processes to their resolution
• supervising corrective/containment mesaures resulting from Audits and Inspections
• representing the Quality Division during Audits and Inspections, and in meetings with third parties
• closely collaborating with senior management to ensure efficient implementation of relevant processes, as well as updating SOPs and/or other Work Instructions (Wis)
• leading supplier qualifications and/or re-qualifications of suppliers and solving quality issues with selected suppliers
• overseeing use of the Quality Management System (QMS) for suppliers" qualification or requalification purposes
• working experience in Cleanroom environment will be considered an advantage

Requirements:

• university education, preferably in a biomedical (biology, biotechnology, pharmacy) or a related field);
• a minimum of 3-5 years of relevant experience working with Medical Devices or Food Quality Management, including direct field work monitoring experience, or direct management/oversight of individuals working in such environment, with a record of relevant accomplishments.
• Interpersonal skills and experience in managing and professionally developing people
• ideally, experience in Quality Management, including Quality Control Activities, Process Management & Improvement
• ideally, experience in managing audits and inspections
• ideally, experience in coordinating and delivering training sessions
• advanced level of spoken and written English.
• strong organizational and time management skills
• excellent interpersonal skills
• driving license category B
• an equivalent combination of education and work experience may be considered to meet the minimum requirements

The company offers:

• an attractive and stimulating international working environment, offering numerous opportunities to meet inspiring people from all over the world
• excellent development opportunities to further own career
• broad scope of trainings in several highly specialized areas
• stable employment (contract of employment).
• relocation assistance, if required
• private medical care plan
• group insurance options
• attractive remuneration package (salary basis PLN 14000 gross)
• healthy and positive work environment