Principal Quality Engineer

• Job title Principal Quality Engineer
• Function Quality
• Sub function Business Process Quality
• Category Senior Manager, Business Process Quality (P8)
• Location Santa Clara / United States of America
• Date posted Apr 28 2025
• Requisition number R-010572
• Work pattern Fully Onsite

This job posting is anticipated to close on May 05 2025. We may however extend this time period, in which case the posting will remain available on www.careers.jnj.com to accept additional applications.

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

Job Function:

Quality

Job Sub Function:

Business Process Quality

Job Category:

Professional

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is currently seeking a Principal Quality Engineer to join our MedTech Quality & Compliance team located in Santa Clara, CA.

The Principal Quality Engineer will spearhead quality assurance initiatives for our business growth including launch excellence programs within Robotic and Digital platforms. This pivotal role will ensure that our products consistently meet the highest quality standards while executing strategic expansion plans and optimizing outsourced manufacturing processes for enhanced efficiency and reliability.

Reporting to Quality and Compliance Transformation Director, the Principal Quality Engineer will collaborate actively with the Q&C and Platform teams to formulate and refine the multi-year product launch Q&C strategy and manage key initiatives across quality and compliance platforms, emphasizing continuous business growth and improvement.

Key Responsibilities:

• Direct and coordinate teams to synchronize business process quality operational and functional initiatives that support overall quality objectives and company goals, resulting in measurable impacts on departmental performance.
• Develop quality-based strategies, owning and implementing strategies, working within various cross functional teams to further the strategy, and driving best quality practices to ensure timely execution of business launch excellence program. This role will lead all aspects of launch excellence in quality managements systems processes end to end throughout the program life cycle.
• Lead multiple large-scale projects across various disciplines to refine the organization's quality business processes, focusing on enhancing operational efficiencies, product quality, and profitability.
• Develop and execute prioritized roadmaps for process improvement opportunities across all functional areas, aligning with strategic business objectives.
• Implement Quality frameworks including furthering effective and fit for purpose Quality Management System requirements as part of launch excellence and best practices to effectively structure and govern quality programs from inception through integration with J&J Business Units/External Manufacturers.
• Drive initiatives for data collection and measurement, develop key performance indicators (KPIs), and perform advanced analytics on critical processes. Required to provide KPI driven updates and program deliverables across global launch teams and will completely own all KPIs impacting quality deliverables.
• Communicate program updates clearly and engagingly to key stakeholders and team members, ensuring timely information dissemination.
• Provide consultation and mentorship to junior team members on quality techniques and processes, offering functional supervision as necessary.
• Integrate Johnson & Johnson's Credo and Leadership Imperatives into team objectives and decision-making processes.

Qualifications:

Education:

• Bachelor's degree in engineering or a related scientific discipline is required.
• An advanced master's degree is preferred.

Required Skills and Experience:

• Minimum of 15 years of relevant experience, with substantial project management experience in global product launches, Supply Chain, site integrations, service, and manufacturing expansion.

• Minimum experience to include at least 5 years in quality engineering/assurance capacity and 10 years in medical device industry. Must have strong working experience and knowledge with Regulation and International standards/requirements such as:

• 21 CFR Part 820/11, EN/ISO 13485, ISO 14971, IEC 60601, EUMDR, Canadian Medical Device Regulations (SOR/98-282), and China (NMPA) regulations.

• At least 5 years of experience associated with large capital equipment medical device manufacturers as Quality and/or Process Excellence/Supply Chain, specifically involving embedded or standalone product-related software.

• Proven effective strong analytical and problem-solving capabilities, along with proficiency in statistical methods, risk management and quality improvement tools (e.g., Six Sigma, Lean).

• Experience working in large complex organization and achieving results through internal and external partners.

• Proven effective communication skills, capable of presenting Quality Systems data and implementation of Quality Management system processes to senior leadership and conducting program reviews across diverse strategic business platforms.

Preferred Skills:

• Familiarity with Agile PLM, SAP, Compliance Wire, PDM Windchill, and other industry-centric IT solutions.
• Proficient in MS Office Suite (Word, Excel) and project management/analytics software.
• Documented success in implementing large-scale transformation and compliance programs while acting as a Change Adoption Agent.
• Prior experience in quality systems remediation and effective root cause analysis leading cross-functional teams.
• Mentorship capabilities in talent development and strong collaboration skills to build and maintain development plans.
• Ability to foster interdependent partnerships and cultivate strong internal and external relationships.

Other:

• This position may require up to 20% plus domestic and/or international travel depending on business needs.

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 (...) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$138,000-$238,050

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: 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 of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. 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.