Job Title: Product Development Specialist
">
Job Description:
">
This is an exciting opportunity to join our team as a Product Development Specialist. As a key member of the product development team, you will be responsible for ensuring product quality during early development phases through to commercial launch.
">
Responsibilities:
">
">
* Responsible for compliance with policies and procedures and applicable national and international regulations.
">
* Leads compliance and improvement activities associated with the quality system (e.g. CAPA, audit programs, personnel training).
">
* Apply thorough, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
">
* Plan, execute, report, and follow-up on quality system audits. Act as an audit escort and/or support in the coordination of backroom activity during inspections as required.
">
* Provide expertise in the areas of quality assurance, controls, and systems to support and develop the company's QMS.
">
* Develop and implement control plans, inspection plans, and testing strategies to ensure product compliance with design and regulatory requirements.
">
* Work closely with suppliers to ensure robust quality agreements are in place, including periodic review of their quality metrics.
">
* Provide ongoing support to the internal teams in the development of products, through first article inspection qualifications, and test method development and approval activities through to commercial launch.
">
* Gather and analyze data to support statistical rational sample testing requirements during early product development and ensure compliance with product specifications, regulations, and internal requirements.
">
* Ensure that all aspects of product development align with company policies and regulatory requirements.
">
">
Required Skills and Qualifications:
">
The ideal candidate will have a Bachelor's degree in engineering or a related technical field and a minimum of 3 years of experience in quality engineering within the medical device industry, preferably with neuro-interventional devices.
">
Benefits:
">
This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention.
">
Others:
">
Does this sound like your next career move? To apply and for more information forward your application to the link provided or contact us.
"],