Description: We are looking for a mid-level Supplier Quality Engineer to complete tasks related to EU MDR compliance.
Day to Day: 1.
Understanding of product control policies and governance for product acceptance 2.
Experience to regulations that drive changes to current processes 3.
Communication of deliverables based on program driven timelines Education and Years’ Experience Required: University Degree in Engineering or related field and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
Hybrid work environment, some onsite is required.
Responsibilities may include the following and other duties may be assigned: Ensures that suppliers deliver quality parts, materials, and services.
Creation of receiving inspection to ensure cost effectiveness.
Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier related problems as they occur.
Review of supplier documentation to ensure good manufacturing practices (GMP) and quality standards are met.
Evaluates suppliers’ internal functions to assess their overall performance and provides feedback in assessment of their operation.
Works with suppliers and internal functions assuring manufacturing processes and documentation with EU MDR regulations Ownership and review of product change orders(ECOs) meeting internal SOPs standards, EU MDR regulations and good manufacturing processes.
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor.
Works independently with general supervision on larger, moderately complex projects / assignments.
Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments.
Contributes to the completion of project milestones .
May have some involvement in cross functional assignments.
Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex .
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
Communication and Influence: Communicates primarily and frequently with internal contacts .
External interactions are less complex or problem solving in nature.
Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
Leadership and Talent Management : May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
Required Knowledge and Experience : Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
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