What are the responsibilities and job description for the Quality Engineer II position at Viant Medical?
Viant Medical, LLC seeks a full-time Quality Engineer II based in Grand Rapids, MI.
Responsible for providing quality engineering support for Operations to ensure that the Quality Systems requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance. Provide QMS support, engage in continuous improvement initiatives with cross functional teams, conduct validation and process verification, and participate in customer facing activities.
Requirements
Bachelor’s degree or equivalent in Industrial Engineering or a related field and 5 years related (progressive, post-baccalaureate) engineering experience in the medical device, healthcare or pharmaceutical industry.
Must also have 12 months of experience with each of the following:
Responsible for providing quality engineering support for Operations to ensure that the Quality Systems requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance. Provide QMS support, engage in continuous improvement initiatives with cross functional teams, conduct validation and process verification, and participate in customer facing activities.
Requirements
Bachelor’s degree or equivalent in Industrial Engineering or a related field and 5 years related (progressive, post-baccalaureate) engineering experience in the medical device, healthcare or pharmaceutical industry.
Must also have 12 months of experience with each of the following:
- Regulatory standards including FDA Quality Systems Regulations, ISO13485, and ISO14971 risk management methodologies.
- Utilizing statistical analysis and validation techniques including Statistical Process Control, Capability Analysis, Hypothesis testing, and Acceptance sampling.
- Interpreting technical engineering drawings and specifications, and working with FMEAs and Control Plans.
- Leading end-to-end test method validation activities and writing comprehensive validation documents.
- Conducting corrective and preventive actions (CAPA) in manufacturing using formal problem-solving tools and comprehensive documentation to address root causes and prevent recurrence.
- Developing and implementing inspection procedures. Employer will accept experience gained concurrently.
