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.
A pre-identified candidate for consideration has been identified.
However, all applications will be considered.
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.
nj.
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For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.
Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.
Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve.
Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential.
At Johnson & Johnson, we all belong.
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 expertise 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.
Key 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.
Qualifications Education.
University/Bachelor or equivalent degree in Science or Engineering field is required.
Experience and Skills.
Required.
A minimum of two (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 Management, Training, Management Review, and Data Analysis.
Knowledge in ISO and or QSR 820 FDA.
Intermediate Microsoft (Excel, Power Point, SharePoint) knowledge.
Previous knowledge in Change Control process.
Skilled at preparing executive briefings and broad communications.
Ability to make proven decisions that will optimally support the business and company policies.
Ability to work in multi-collaborative environment and rapidly shift on assignments.
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 co-workers and the complementary teams.
Other.
Strong oral and written communications skills is required.
ASQ Certification(s) is preferable.
The highest Ethical & Integrity Standards.
This position may require a 10% of domestic travel.
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 www.
areers.
nj.
om.