Quality Manager/Greenfield
Okolice Tychów Quality Manager/Greenfield
Okolice Tychów
NR REF.: 1129430
For our Client - international new greenfield company from medical devices industry based near Tychy, we are looking for Quality Manager.
Responsibilities:
Required Qualifications: ·
Offer:
Okolice Tychów
NR REF.: 1129430
For our Client - international new greenfield company from medical devices industry based near Tychy, we are looking for Quality Manager.
Responsibilities:
- Lead the growth and development of the Quality Organization in the plant and assure a permanent state of quality compliance
- Improve existing capabilities and add new (innovative) capabilities to meet changing and increasing customer needs focused on compliance
- Set up the quality organization to support smooth product/project transfer into the OPS organization and assure successful ramp up
- 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,
- Communicate results of the KPI’s and quality goals to the Plant Management Team and the regional organization
Required Qualifications: ·
- Bachelor or Master Degree in Engineering or other technical/Scientific discipline
- Strong understanding of the quality management for the medical and primary pharmaceutical packaging’s, like: ISO 13485, 21CFR820, 21CFR210/211 and ISO 15378
- Broad knowledge processes and regulatory requirements
- English Language Proficiency at CEFR C level
- Knowledge of Lean Six Sigma tools and Change Execution Management
- Strong understanding of market, customer, technology and emerging trends
- Minimum ten years professional experience with at least 5 at a supervisory level
- Proven experience in customer relationship building
- Experience in auto-injector and multi-dose drug delivery devices and/or Inhalation drug delivery devices
Offer:
- possibility to develop in new structures
- international team
- benefits
- greenfield project
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