Site QA Manager
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Medical Devices organization, based in Noord-Holland Netherlands.
Medical Devices company.
ROLE DESCRIPTION
The Site Quality Manager leads the growth and development of the Quality Organization in the plant and assure a permanent state of quality compliance. He or she will improve existing capabilities and add new (innovative) capabilities to meet changing and increasing customer needs focused on compliance and will set up the quality organization to support smooth product/project transfer into the OPS organization and assure successful ramp up.
RESPONSIBILITIES
Leadership
• Provides direction and leadership to the Quality Organization
• Manages the quality organization focused on quality control (Metrology) and quality assurance (QA)
• Works together with the production department leaders to develop and execute long-term strategies and process improvement
• Implements staff-to-strength and cross-training initiatives to ensure strong morale and retention and to provide appropriate challenges to a talented, diverse, and unique creative team
Quality
• Takes ownership of the QMS within the plant
• Develops and implements processes to meet customer and internal needs
• Define, monitor and manage dedicated Quality KPI’s for the organization (with Management Team members) and for department individuals
• Accountable for (final) release of materials and (sterile) products
• Ensures QMS documents and procedures comply with company and applicable standards
• Leads the Site Quality Council
• Management representative according to the requirements defined in the ISO 13485, 21 CFR820, ISO 9001
• Supports audits by customers and regulatory authorities
Finance and Reporting
• Ensuring execution of agreed budget, implementation of investments in quality organization
• Report status and results on Analysis of Quality Data on a monthly basis
• Communicate results of the KPI’s and quality goals to the Plant Management Team and the organization
Customer and Supplier relations
• Actively participates and supports customer visits, programs, and audits
• Supports the development and presentation of proposals in close collaboration with proposal developers and BDMs
• Effectively communicates the value proposition to internal and external customers, suppliers and the business community
• Executes the program according to customer needs and satisfaction
• Develops and maintains effective working relationships with customer peers,
Communication:
• Internal: Frequent communication with Director Quality & Regulatory Affairs, Business Development Managers, Plant Quality organization and site Project/Program managers, Quality and Process Engineering Management, pre-production organization and staff.
• External: Customers, suppliers, all other business relations
REQUIREMENTS
• Bachelor or Master Degree in Engineering or other technical discipline
• Strong understanding of the quality management systems for the medical and primary pharmaceutical packaging’s, like: ISO 13485, 21CFR820, ISO15378.
• Broad knowledge processes and regulatory requirements
• Strong understanding of market, customer, technology and emerging trends
• Strong leadership skills
• Strong ability to establish and implement structures and processes
• Strong and effective communication skills, including verbal, written, presentation and negotiation
• English Language Proficiency at CEBR C level
• Decision making and prioritization skills
• Motivated self-starter who is able to manage multiple tasks and challenges
• Knowledge of Lean Six Sigma tools and Change Execution Management
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim Thuijs.