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 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.

Education:

• A minimum of a Bachelor Degree of Science or Engineering field is required.

Experience and Skills: Required:

• A minimum of 2 years of experience in medical device manufacturing or related industry experience
• Demonstrated knowledge of quality system principles, practices, and processes such as CAPA, Change Design, Training, Management Review, and Data Analysis
• Prior experience in ISO 13485 and or QSR 820 FDA
• Skilled Microsoft (Excel, Power Point, SharePoint) knowledge
• Previous knowledge in Windchill

Preferred:

• Excellent interpersonal relations and communication skills
• Knowledge of specific business software and software applications such as EtQ, ComplianceWire and/or Minitab.
• Ability to communicate effectively with a diverse collaborator.
• Ability to work cooperatively with coworkers and the complementary teams.

Other:

• Strong oral and written communications skills abilities is required.
• Skilled at preparing executive briefings and broad communications is required.
• Ability to make proven decisions that will optimally support the business and company policies is required.
• Ability to work in multi-collaborative environment and rapidly shift on assignments is required.
• ASQ Certification(s) is preferable.
• The highest Ethical & Integrity Standards.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit