6 Senior Quality Engineer-Operations Jobs in Milpitas, CA
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Senior Quality Engineer-Operations
$111k-132k (estimate)
Full Time | Pharmaceutical
1 Month Ago
Johnson & Johnson is Hiring a Senior Quality Engineer-Operations Near Milpitas, CA
Description:Johnson & Johnson Surgical Vision is recruiting for a Senior Quality Engineer-Operations located in Milpitas, 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/.
The Senior Quality Engineer will work collaboratively with manufacturing, manufacturing engineering and R&D to ensure quality standards are met across all our product lines. The Senior Quality Engineer is responsible for providing guidance on audits of all quality system categories to assess compliance to good manufacturing practices, and equipment engineering system. This person plans and conducts projects and assignments with technical responsibility.
Key Responsibilities:
– 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:
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.
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 will work collaboratively with manufacturing, manufacturing engineering and R&D to ensure quality standards are met across all our product lines. The Senior Quality Engineer is responsible for providing guidance on audits of all quality system categories to assess compliance to good manufacturing practices, and equipment engineering system. This person plans and conducts projects and assignments with technical responsibility.
Key Responsibilities:
- Supports the application of quality engineering and quality compliance in support of demanding projects in the areas of:
- Supply chain (life cycle engineering, manufacturing, or assembly)
- New product development / new product introduction / new process introduction
- Quality systems / business improvement
- Develops standard operating procedures, specifications, and provides technical and validation support.
- 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 enforcement of GMP, ISO and FDA requirements
- Provide statistical support and analytical problem solving for manufacturing, technical services, and product development in order to identify root cause of problems
- Audit and approve manufacturing, quality, engineering, and validation qualification documents for conformance to Johnson & Johnson business practices and departmental procedures
- Support Process Improvement activities
- Support processing of product nonconformances in the manufacturing floor
- Support Nonconformance (NC) and Corrective Action and Preventive Action (CAPA) activities
- Other responsibilities may be assigned and not all responsibilities listed may be assigned
- Bachelor’s degree or equivalent in Engineering, Computer Science or STEM (Science, Technology, Engineering, Math) related field.
- A minimum of 4 years of work experience.
- Experience in medical device industry with knowledge of 21 CFR 820, and/or EUMDR
- Computer proficiency with MS Office
- Strong technical understanding of manufacturing equipment and processes
- Experience with GDP, and GMP
- Experience with root cause analysis and Corrective Action / Preventive Action (CAPA)
- Experience running projects and demonstrating project leadership abilities
- Industry experience with capital equipment
- Experience with capital equipment validations
- This position will be located in Milpitas, California and may require up to 10% domestic or international travel.
- 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)).
- This position is eligible to participate in the Company’s long-term incentive program.
- Employees are eligible for the following time off benefits:
– 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
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.
Job Summary
JOB TYPE
Full Time
INDUSTRY
Pharmaceutical
SALARY
$111k-132k (estimate)
POST DATE
06/02/2024
EXPIRATION DATE
07/28/2024
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