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Quality manager

Titel: Quality manager
Werkgever: Ajilon
Plaats: Drachten
Provincie: Friesland

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Job Profile The Quality Manager monitors the quality assurance activities in accordance with applicable standards and regulations. Her or she is responsible for ensuring Regulatory Compliance and overseeing Quality Assurance and Quality Control activities for the plant (including manufacturing, product development, and post market monitoring and improvement). The Quality Manager develops, executes and manages the three to five year Quality Strategic Plan and ensures projects are completed within schedule and on budget. The Quality Manager is called upon to provide technical leadership and functions as an advisor to a plant or subunit regarding tasks, projects and operations. This individual interprets and executes policies and procedures that affect functional units. They recommend modifications to Operating policies, procedures and practices that can affect the operating unit. Qualifications • Management Representative: Responsible for the Quality Department including the evaluation of Quality Control results and the decision to release products. Ensures that the quality system is established and maintained efficiently, reports the quality system performance to management for review and promotes awareness of regulatory and customer requirements throughout the organization • Coordinates team work to ensure equitable management and the achievement in a timely and sustainability manner of various program activities under his/her responsibility • Manages quality assurance activities for development (compliance with procedures, risk analysis, quality plan) and the manufacturing of the clients products (quarantine and release, calibration, reports of non-compliance analysis, trend analysis) • Develops and manages the budget for the quality organization • Hires, coaches and develops employees to continually improve their skills and thus prepare the next generation of leaders • Works in collaboration with the other department to prioritize training of employees • Works to improve the execution of the quality system, and ensures proper execution • Is authorized to accept notice of regulatory inspection on behalf of management • Develops metrics for monitoring and assessing product and processes, and initiates investigation and improvement activities as needed • Assumes any other responsibilities or tasks as assigned • Collaborates with other Quality Leaders and participants on projects with participants from other plants • Must be available to travel internationally • Must be very comfortable with verbal and written communication • High availability

Education & Experience • Bachelor of Science (BSc) or Engineering (B.Eng.), Master and/or specialization in Quality management in regulated industries and good knowledge of molecular biology is preferred • Minimum 9 years of experience work experience, with 4-6 years in Quality • Minimum 5 years of experience in the medical device industry or a related field of biotechnology in a GMP environment • Experience in managing people Skills and competences • Knowledge of ISO 13485 and QSR (Quality System Regulations); IVD Directive • Knowledge of laws, regulations, standards and guidelines governing the sale of medical devices in Europe, the United States and Canada Need to Know • Strong written and verbal communication skills Need to be • Good interpersonal skills • Able to work independently • Takes initiative • Dependable • Shows good attention to detail • Excellent judgment and risk management skills • Good organizational skills

Company profile Our client that you will be working for designs, develops, manufactures, markets, sells, delivers and services innovative automation solutions for microbiology laboratories worldwide.

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