Quality Systems Analyst, Change Control

Johnson & Johnson; Plymouth; On-site; USD 69,000 - 103,000; Full time

Job description

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.

Job Function: Quality

Job Sub Function: Quality Systems

Job Category: Professional

All Job Posting Locations: Plymouth, Minnesota, United States of America

Job Description:

Sterilmed Inc. is recruiting for a Quality Systems Analyst, Change Control, located in Plymouth MN, US.

As part of the Quality Systems team, we have responsibilities such as coordinating the change control documentation and approval process and providing 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 detailed understanding of regulations, process criteria, and business impact for decision-making and implementation of actions. You'll need to lead and support the current quality change control system and recommend improvements for the areas you will be supporting.

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

Key Responsibilities:

• Monitor and track alignment to J&J Quality Standards and any other quality system initiatives.
• Ensure quality systems are effectively deployed.
• Responsible for Change Control activities as a Quality Systems SME.
• Support and coordinate change control needs for the site.
• Facilitate and guide change owners' activities.
• Report metrics related to areas of support to appropriate review boards such as Management Review, Data review board, periodic metrics reporting, etc.
• Responsible for communicating business-related issues or opportunities to the next management level.

Qualifications - External

Education:

• A Bachelor’s or equivalent university degree in Science or Engineering field is required.

Experience and Skills:

Required:

• 2-4 years of experience in Medical Device manufacturing or related proven experience.
• Proven knowledge of quality system principles, practices, and processes such as Change Control, Change Design, and Data Analysis.
• Prior experience in ISO 13485 and or QSR 820 FDA.
• Ability to prioritize in a fast-paced environment.
• Excellent interpersonal relations and communication skills.
• Skilled Microsoft (Excel, PowerPoint, SharePoint) knowledge.

Preferred:

• Knowledge of specific business software and software applications such as Windchill, EtQ, Compliance Wire, Minitab, etc. is preferable.
• Ability to communicate effectively with a diverse collaborator.
• Ability to work cooperatively with coworkers and complementary teams.
• Strong oral and written communication skills abilities.
• Skilled at preparing executive briefings and broad communications.
• Ability to make confirmed decisions that will optimally support the business and company policies.
• Multi-collaborative environment and rapid shift on assignments.
• ASQ Certification(s) is preferable.

Other:

• Up to 10% of domestic travel is required.

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.careers.jnj.com.

The anticipated base pay range for this position is: $69,500-$102,350

Additional Description for Pay Transparency:

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time off benefits:
• Vacation – up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year