Job ID 19000H8A
Available Openings 1
PURPOSE AND SCOPE:
Provides Design Assurance expertise from a Design Control and Quality Engineering perspective during the stages of product development to ensure robust product design, resulting in improvement in overall customer satisfaction. Works with R&D to provide Design Assurance expertise with the intent of Designing Quality in the Products during new product design and development or during significant modification to the existing products by utilizing the philosophy of ‘Quality by Design' (QbD). Assist Design Assurance Director to create an efficient design assurance system and processes within the quality organization to provide R&D and GMQ-Operation teams the support and guidance required for enhanced design quality yet more efficient and structured product development method, resulting in an improvement in overall customer satisfaction and reduction in overall product development cost to the organization.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Leads operational efforts through subordinates, constructs strong framework of knowledge and processes with the intent of building robust Design Control system. Ensures the operations effective achievement of goals within the assigned business unit(s).
- Provides assistance to improve speed to market, reduction of risks to patients, regulatory compliance, and continuous quality improvement with the goal of reduction in overall post market issues.
- Assures reliability targets and testing are appropriately implemented, suitable quality tools are deployed and utilized on projects, the appropriate level of design verification and validation activities are performed, and project schedules are met.
- Review change requests related to design change and process change with regards to proper Design Control and Quality Engineering application.
- Assists with review of the development process and development of engineering deliverables to support the compliant and high quality design, use, delivery, and maintenance of the product.
- Assists with identification of possible design deficiency as early as possible in the design life cycle and determining the adequacy to meet regulatory requirements and engineering design safety & efficacy of products to increase the likelihood that the design meets or exceeds reliability requirements, FDA regulatory requirements, and customer expectations.
- Manages Design Assurance function including talent acquisition, staff development, retention, and budgets. Oversee technical performance of DA staff on assigned project activities. Deploys and utilizes staff across a wide variety of research, product concept, and development activities.
- Acts as technical expert in Quality Engineering and Design Control to staff and project teams. Ensures regulatory requirements compliance related to hardware design and software verification and validation activities.
- Serves as technical reviewer for projects, performs preliminary and critical design reviews, as appropriate, reports issues related to project technical performance.
- Develops effective cross-functional relationships with R&D, sustaining engineering and site management to meet departmental and organizational goals.
- Provide leadership, guidance and coaching for all direct reports to maintain an engaged and productive workforce.
- Collaborates with employees in the establishment of clear and concise development plans to ensure succession planning and the advancement of future leaders within the organization.
- Provide technical guidance.
- Assist with various projects as assigned.
- Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
- The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Travel up to 25%
- Be responsible for the direct supervision of various levels of Design Quality Assurance staff.
- Bachelor's Degree required; Advanced Degree desirable
EXPERIENCE AND REQUIRED SKILLS:
- 7 – 10 years' related experience.
- 1+ years' supervisory or project/program management experience preferred.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
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