Sr Quality Systems Engineer

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:

Athens, Georgia, United States of America, Cincinnati, Ohio, United States of America, Jacksonville, Florida, United States of America, Raritan, New Jersey, United States of America, Raynham, Massachusetts, United States of America, San Lorenzo, Puerto Rico, United States of America, Santa Clara, California, United States of America, Warsaw, Indiana, United States of America

Job Description:

Johnson & Johnson MedTech is recruiting for a Senior Quality Systems Engineer. The preferred location for this role is in Raritan, New Jersey. The role can also be performed in Raynham, MA, Cincinnati, OH, Jacksonville, FL, Athens, GA, Warsaw, IN, Santa Clara, CA or San Lorenzo, PR.

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

This position is responsible for monitoring and reporting the performance of quality systems processes within Johnson & Johnson MedTech Quality Systems. The role will head key initiatives aimed at sustaining and improving quality system performance across various Business Units.

The Senior Quality Systems Engineer will drive consistency and correlation of Quality Systems process data presented from the various QS elements across data forums. This role prepares and presents various reports/presentations to convey performance as well as issues/trends/opportunities for improvements to top management.

The role will be a data lead and steward for Quality System data requests as required by the Quality and Compliance organization to support key initiatives. This role will support the collection of data for ad hoc queries and activities within the Quality Systems & Digital Services - Process and Performance team that enhance and help drive innovation in our Quality Management System. This role will also support different projects to drive simplification and efficiency across MT QS (inclusive of process and/or procedure reduction/simplification).

This position also supports the integration of quality system performance processes across acquisitions and stays informed about enterprise solutions and their impact on quality systems.

Key Responsibilities:

• Monitor key quality system performance metrics, communicate status, and identify improvement opportunities across MedTech organizations.
• Ensure proper execution of data collection/metric reporting processes across MT to ensure timely and accurate publication of required deliverables including monthly and quarterly reports.
• Review individual Business Unit results and commentary to draft summary documents conveying Business Unit and MT level trends.
• Drive action plans for recovery of QS process performance when negatively trending and proactively identifying areas for improvement to avoid negative trends.
• Ensure consistent messaging regarding quality system performance from monthly reviews into QSMR/EQR/QCLT.
• Point of contact to address and resolve data and ad hoc Quality Systems requests from Leadership.
• Provide support for quality systems projects including performance improvements (IPREVENT, etc.) and/or Quality Systems simplification and efficiency projects (Procedure reductions, etc.).
• Integrate performance process and metrics into key acquisitions.
• Partner with MT Quality Systems and Digital Solutions leaders to improve QS performance metrics/trending and communications through the preparation of proactive metric reviews and individual Business Unit review presentations.
• Frequently present to leadership/upper management, as needed.
• Providing support for internal and external audit processes.
• Collaborate with the Data Analytics team to address issues as they arise, maintaining smooth monthly reporting operations.
• Support additional tasks such as project management for process improvement initiatives in MedTech Quality Systems and updating procedures within the PLM system.

Qualifications

Education:

• Bachelor’s or equivalent degree is required, preferably in Engineering, Life Sciences, Business, or a related concentration.

Experience and Skills:

Required:

• 2-4 years of proven experience in MedTech or Pharmaceutical Industry
• Strong analytical skills
• Experience in creating presentations
• Excellent written and verbal communication skills
• The candidate should possess strong leadership and influencing skills
• Strong technical, planning, and execution skills, along with the capacity to analyze and prioritize risks.

Preferred:

• Experience in Quality Systems
• Direct experience supporting FDA and global regulatory inspections.
• Previous experience in highly regulated medical device and/or pharmaceutical industries
• Ability to communicate and partner up effectively across teams/Business Units
• The ability to foster a collaborative work environment, manage multiple assignments, and adapt to rapidly changing priorities.
• Familiarity with PowerBI and/or Qlik.
• Strong presentation skills.

Other:

• This position requires 10% domestic and international travel.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law.

We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$77,000- $124,200

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. • 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: o Vacation – up to 120 hours per calendar year o 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 o Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year • Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.