Quality Systems Specialist Engineer

Sterilmed a member of the Johnson & Johnson Family of Companies is recruiting for a Quality Systems Specialist Engineer to be located at Plymouth, MN.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

As a Quality Systems Specialist Engineer you will have responsibilities in coordinating the change control documentation and approval process, provide quality support for technology transfer and improvement of existing processes. Conduct investigations, collection of data, analysis of trends and preparation of reports for assigned quality processes.

This role requires to have detailed understanding of regulations, process criteria, and business impact for decision making and implementation of actions. You'll need to evaluate the current quality systems and recommend improvements of quality system elements.

We need your expertize and support to prepare for audits and inspections, and on the development, implementation, and review of standard operating procedures for interactions with internal and external customers.

Responsibilities

• Responsible for Change Control activities, Training SME, and Quality Systems SME;

• Support and coordinate change control needs for the site, facilitating and providing guidance on Change Control.

• Reporting metrics related for areas of support to appropriate review boards such as Management review, Data review board, periodic metrics reporting, etc.

• Responsible for presenting business related issues or opportunities to next management level.

• Coordinate and participate in special projects as assigned; act as backup support for Quality System roles as part of the Quality Systems team.

• Responsible for communicating business related issues or opportunities to next management level.