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Senior Quality Engineer - 2406170430W

Description

Biosense Webster is recruiting for a Senior Quality Engineer to be located in Santa Rosa, CA.

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 Senior Quality Engineer provide technical leadership by developing, establishing, and maintaining quality engineering methodologies, systems, and practices. This position also drives product/process improvements with the objective of product safety and end-user satisfaction.

Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity!

Key Responsibilities:

• Consults on development of quality improvements and recommends alternatives. Guides the architecture, governance, and measurement of assigned programs. Leads the development and implementation of system level improvement plans across a variety of areas to increase efficiency, reduce cost and streamline operations.

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

• Leads Purchasing Control, Supplier Control, and Receiving Inspection to ensure that the finished goods devices, assemblies, subassemblies, and components are manufactured according to product specifications.

• Support Manufacturing with equipment qualifications (IQ/OQ/PQ), process validations and process improvements.

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

• Partners with external suppliers to review and assess any design or process changes that may impact the product specifications or overall performance. Helps build qualification strategies to implement complex changes.

Qualifications

Education:

• A minimum of a Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Process Engineering, or equivalent degree is required.

Experience and Skills:

Required:

• A minimum of 2 years of work experience in medical device industry.

• Understanding of regulatory requirements, specifically 21 CFR 820, ISO 13485, and ISO 14971.

• Experience with root cause analysis tools and methods.

Preferred:

• Strong collaboration and influence skills (build relationships, leverage others, align and work towards shared outcome-based goals).

Other:

• Excellent Communications Skills (oral, written, presentation). is required.

• This position may require up to a 10% of domestic and/or international travel.

The anticipated base pay range for this position is $76,000 to $121,900. In the Bay Area, the anticipated base pay range for this position is $89,000 to $140,185.

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

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

This job posting is anticipated to close on 03/11/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

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.

Primary Location NA-US-California-Santa Rosa

Organization Biosense Webster Inc. (6010)

Relocation Eligible: Yes - Within Country

Travel Yes, 10 % of the Time

Job Function Quality Engineering

Req ID: 2406170430W