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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:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Santa Rosa, California, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Senior Quality Engineer ! This position will be located in Santa Rosa, California.

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/.

Position Summary:

In this role, you will provide technical leadership on a daily basis by developing, establishing, and maintaining quality engineering methodologies, systems, and practices. This position will also drive product/process improvements with the objective of product safety and high customer satisfaction.

Key Responsibilities:

• Must be able to interface well with Management, Manufacturing and R&D Engineering, and Supply Chain.

• Work with various departments to ensure timely closure of CAPAs, NCMRs, and Complaints. Document deficiencies, including root cause, corrective and preventive action plans. Ensure action plans are implemented in a timely manner.

• Lead and support test method validation plans/protocols and reports.

• Assist with risk analysis activities and maintaining up to date risk management documents.

• Establish Quality Inspection Plans for the release of components, assemblies, and finished devices. Conduct quality inspections as needed.

• Support Manufacturing with equipment qualifications (IQ/OQ/PQ), process validations and process improvements. Includes the use of various statistical techniques and quality tools.

• Experienced with statistical techniques, including design of experiments (DOE); able to analyze results.

• Evaluate significant product and/or process changes and enhancements which reduce defects, improve yields, and lower product cost.

• Support quality management programs such as supplier selection and certification. Perform supplier evaluations as needed to assure supplier capabilities including the assessment of the adequacy of inspection methods, manufacturing practices, and control and quality procedures to deliver conforming products in a timely manner.

• Lead supplier audits and works with suppliers to resolve audit findings and/or nonconformances.

• Perform internal audits as needed.

• Responsible for quality engineering review of Document Change Orders.

• Devise and review specifications for products or processes.

• Set requirements for raw material or intermediate products for suppliers and monitor their compliance.

• Ensure adherence to regulatory requirements, and health and safety guidelines.

• Supervise inspectors, technicians and other staff and provide guidance and feedback.

• Oversee all product development procedures to identify deviations from quality standards.

• Inspect final output and compare properties to requirements.

• Manage the sterilization program.

Qualifications:

Education:

A Minimum of a Bachelors or equivalent University degree is required with a focus in Mechanical Engineering, Biomedical Engineering, Process Engineering, or equivalent degree preferred.

Required Skills:

• 4+ years relevant experience in medical devices.

• Highly motivated and self-directed with a strong sense of urgency, with an ability to pull in resources from other departments.

• Ability to deliver, meet deadlines and be results oriented.

• Detail-oriented, thorough, observant.

• Excellent Communications Skills (oral, written, presentation) at different organizational levels.

• Experience with root cause analysis tools and methods.

• Understanding of regulatory requirements for the medical device industry, specifically 21 CFR 820, ISO 13485, and ISO 14971.

Other:

• This position has an estimated annual salary of 77,000- 124,200 USD$

• • 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)).– 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 yearFor additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

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 :

77,000- 124,200 USD$

Additional Description for Pay Transparency:

• This position has an estimated annual salary of 77,000- 124,200 USD$ • - 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)). – 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 For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits