Develop, establish and maintain quality engineering methodologies, systems, and practices which meet Nuvaira, customer, and regulatory requirements. Provide focused design assurance, quality engineering, and quality systems support.
- Provide input to design and manufacturing material specifications, drawings, inspection procedures, and manufacturing procedures to ensure that the resulting products can be adequately manufactured and tested.
- Develop and/or provide support for risk assessments, FMEA (Design and Process), design V&V, process qualification, process capability, gage R&R and production control plans.
- Develop and qualify test and inspection methods for use in validation, verification, first article, manufacturing, and incoming inspection.
- Assist with the investigation, analysis and resolution of design or manufacturing related material or product problems that arise.
- Provide support and technical guidance for identifying and resolving new product development and current design manufacturing quality issues.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Participate in and provide quality engineering support for continuous improvement activities related to manufacturing and inspection.
- 3+ years of medical device experience with BS in engineering related discipline.
- Demonstrated use or understanding of Quality tools/methodologies including SPC, DOE, GR&R, FMEA, CAPA, inspection method qualification and process validation, and equipment validation.
- Demonstrated interpersonal skills with the ability to work within a team environment.
- Strong written/verbal communication skills.
- Proficiency with Microsoft Office programs.
- Experience with or knowledge of FDA, ISO/MDD/MDR standards.
- Experience in risk management, design assurance, design validation/verification and change control.
- Experience with Six sigma problem solving methodologies.
Physical Job Requirements:
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Upon request, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.
Nuvaira is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.