Ionetix is a growing company, with revolutionary cyclotron technology. 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.
Ionetix is seeking a full-time Quality Assurance Manager to work in Lansing, MI. This position ensures company products and services meet quality standards with the opportunity to develop quality control processes.
The Quality Assurance Manager has responsibility for but not limited to:
Build and develop the Quality Assurance Program and System.
Effectively work on cross functional teams to establish appropriate processes pertaining to quality.
Serve as a technical leader and build trust with customers and suppliers.
Lead a Continuous Improvement Team, CAPA team, and work with customers and suppliers to resolve product quality issues.
Perform on-site and remote training to assist operations in achieving compliance with ISO guidelines and other regulatory requirements.
Develop and maintain strong knowledge of cyclotron operations.
Work closely with manufacturing, engineering, operations, and other functional areas to evaluate actual or potential product failures.
Investigate, determine root cause, and resolve product failures.
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 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.
This position receives competitive wage, commensurate with experience, and an excellent benefits package, including medical, dental, vision, life insurance, 401(k) and match, and paid time off.
Ideal Candidates will possess:
Bachelor’s degree in a science or technical related field of study
Five or more years’ experience in quality, preferably in the medical device industry
Two or more years in a lead quality or management role
Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE), preferred
Ability to develop and maintain a quality system
Knowledge of medical device quality system (ISO9001 or ISO 13485), preferred
Knowledge of cyclotron operations, preferred
Statistical analysis skills
Strong computer skills in electronic quality systems (i.e.Onmify, SimpCloud, etc.)
Experience participating in internal and external audits (e.g., FDA, Notified Body, Supplier)
Strong organizational and time management skills
Experience with corrective and preventative action (CAPA), complaint investigation, field action processes and risk management
Excellent skills in both verbal and written communications
Effective interpersonal skills
Ability to travel up to 20% of the time
About Ionetix Corporation
Ionetix Corporation is a pioneering radiopharmaceutical end to end solutions provider for cardiac PET. We are changing the paradigm when it comes to access to one of the most accurate PET imaging agents for the detection of coronary artery disease, Ammonia N-13. Until now, this radiopharmaceutical was only available to a select group of institutions due to its very short half-life and the need for a large and expensive cyclotron on site. Ionetix provides virtually any hospital or private center with on demand Ammonia N-13 doses without the need to purchase a cyclotron!
