Ionetix is seeking a full-time Quality Engineer in Lansing, MI. We are a growing company, with revolutionary cyclotron technology.
At Ionetix, we enable healthcare providers to provide highly accurate cardiac PET imaging, offering the highest quality of diagnostic capability of nuclear imaging services to implement and improve cardiac PET programs.
The Quality Engineer ensures company products and services meet quality standards by developing quality system processes and leading associated document control activities.
The Quality Engineer has responsibility to, but not limited to:
Work effectively on cross functional teams to establish appropriate processes pertaining to quality.
Serve as a technical leader and builds trust in working with customers and suppliers.
Serve as a document control leader for site procedures and instructions in support of the quality management system.
Lead Continuous Improvement initiatives, CAPA team, and work with customers and suppliers to resolve product quality issues.
Develop, manage, and assist with the implementation and maintenance of the Quality System.
Perform on-site and remote training to assist operations in achieving compliance with ISO guidelines and other regulatory requirements.
Develop and maintain keen knowledge of cyclotron operations.
Work closely with manufacturing, engineering, operations, service and other functional areas to evaluate actual or potential product failures.
Investigate, determine root cause, and resolve product failures.
Log and track complaints and CAPA records.
Contribute to product quality, safety, and customer satisfaction related decisions.
Lead and support internal and external supplier audits and inspections.
Develop improvement plans and tracks customer quality.
Monitor and advise on product quality performance and publish data and reports regarding the effectiveness of the quality management system in achieving the product performance goals.
Contribute to the development and implementation of product test plans including verification and validation of products and processes.
Serve as a resource in validations, applicable to processes and product.
Perform standard quality engineering reviews (including change reviews) of design documentation for compliance with stated requirements, including supplier quality and company quality records.
Work with manufacturing and engineering to address supplier quality; making improvements to operations to enhance efficiency and quality.
Work with Manufacturing Engineering and Materials in shared ownership of the MRB process and serve as the quality representative on the Materials Review Board.
This position receives a competitive salary, commensurate with experience, and an excellent benefits package, including medical, dental, vision, life insurance, 401(k) and match, and paid time off.
Ionetix is an Equal Opportunity Employer
Ideal Candidates will possess:
Bachelor’s degree in a science or technical related field of study
Five (5) + years’ experience in Quality, preferably in the medical device industry
Two (2) + years in a lead quality or management role
Certified Quality Auditor (CQA) or Certified Quality Engineer (QCE), preferred
Knowledge of medical device quality system (ISO 9001 or ISO 13485)
Statistical analysis skills
Strong computer skills in electronic quality systems (i.e.Omnify, Simploud, etc.)
Experience participating in internal and external audits (e.g., FDA, Notified Body, Supplier)
Experience with corrective and preventative action (CAPA), complaint investigation, field action processes and risk management
At Ionetix, we enable healthcare providers to provide highly accurate cardiac PET imaging, offering the highest quality of diagnostic capability of nuclear imaging services to implement and improve cardiac PET programs. We are a growing company, with revolutionary cyclotron technology.