Johnson Johnson Surgical Vision is recruiting for a Staff Quality Engineer-Complaint Investigations located in Milpitas, California.

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.jnj.com/.

The Staff Quality Engineer will work collaboratively with other quality groups, manufacturing engineering and RD to ensure quality standards are met across all JJSV Equipment product lines. This individual will be responsible for providing expertise on complaints/complaint investigations. This individual will plan and conduct projects and assignments with technical and strategic input. The Staff Quality Engineer will generally operate more independently and may mentor or coach less experienced Quality Engineers.

Key Responsibilities:Complete, review and approve complaint investigations.Leads process improvement activities for complaint investigations.Supports the application of quality engineering and quality compliance principles in support of demanding projects.Develops and implements projects to achieve governance objectives; tracks progress against schedules; provides timely status reports; and communicates status to management.Provide support and expertise in the implementation and compliance of GMP, ISO and FDA requirements.Provide statistical support and analytical problem solving to identify root cause of problems.Coordinates and leads NC and CAPA investigations in compliance with Quality System elements to determine root cause and corrective actions.Other responsibilities may be assigned and not all responsibilities listed may be assigned.

Johnson Johnson Surgical Vision is recruiting for a Staff Quality Engineer-Complaint Investigations located in Milpitas, California.

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.jnj.com/.

The Staff Quality Engineer will work collaboratively with other quality groups, manufacturing engineering and RD to ensure quality standards are met across all JJSV Equipment product lines. This individual will be responsible for providing expertise on complaints/complaint investigations. This individual will plan and conduct projects and assignments with technical and strategic input. The Staff Quality Engineer will generally operate more independently and may mentor or coach less experienced Quality Engineers.

Key Responsibilities:Complete, review and approve complaint investigations.Leads process improvement activities for complaint investigations.Supports the application of quality engineering and quality compliance principles in support of demanding projects.Develops and implements projects to achieve governance objectives; tracks progress against schedules; provides timely status reports; and communicates status to management.Provide support and expertise in the implementation and compliance of GMP, ISO and FDA requirements.Provide statistical support and analytical problem solving to identify root cause of problems.Coordinates and leads NC and CAPA investigations in compliance with Quality System elements to determine root cause and corrective actions.Other responsibilities may be assigned and not all responsibilities listed may be assigned.

Education:

Bachelor’s or equivalent degree in Engineering, Computer Science or STEM (Science, Technology, Engineering, Math) related field.Experience and Skills:

Required:

A minimum of 6 years of relevant work experience.Ability to engage and manage multi-level and multi-discipline project work teams to coordinate activities related to complaint investigation and closure.Strong influencing and negotiation skills at all levels.Effective communication (written, verbal, presentation), teamwork and leadership skills.Ability to perform job duties by demonstrating initiative and operating autonomously.Experience in medical device industry with knowledge of 21CFR820, EUMDR.Preferred:Strong technical understanding of manufacturing equipment and processes.Experience with GxP.Experience with Capital Equipment.Other:This position may require up to 10% domestic or international travel.The anticipated base pay range for this position is $91,000 to $147,200.In California Bay Area - The anticipated base pay range for this position is $105,000 to $169,050.

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 yearSick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar yearHoliday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar yearAdditional 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.

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.

Education:

Bachelor’s or equivalent degree in Engineering, Computer Science or STEM (Science, Technology, Engineering, Math) related field.Experience and Skills:

Required:

A minimum of 6 years of relevant work experience.Ability to engage and manage multi-level and multi-discipline project work teams to coordinate activities related to complaint investigation and closure.Strong influencing and negotiation skills at all levels.Effective communication (written, verbal, presentation), teamwork and leadership skills.Ability to perform job duties by demonstrating initiative and operating autonomously.Experience in medical device industry with knowledge of 21CFR820, EUMDR.Preferred:Strong technical understanding of manufacturing equipment and processes.Experience with GxP.Experience with Capital Equipment.Other:This position may require up to 10% domestic or international travel.The anticipated base pay range for this position is $91,000 to $147,200.In California Bay Area - The anticipated base pay range for this position is $105,000 to $169,050.

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 yearSick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar yearHoliday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar yearAdditional 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.

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.