Easter Seals Jobs

Senior Quality Engineer - 2406200957W

Description

Johnson & Johnson Vision Care is recruiting for a Senior Quality Engineer , to be located in Jacksonville, FL . This is a fully onsite position.

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/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential. At Johnson & Johnson, we all belong.

Looking for a seasoned individual contributor, who works independently with minimal supervision. Implements processes and activities related to fulfilling the Quality Assurance requirements for the organization's products. Develops close partnerships with customers and key stakeholders. Uses data to identify risks and improvement opportunities. Implements risk mitigations and process improvements with support. Escalates issues and risks as required.

The Sr. Quality Engineer will lead computer software validation (CSV) project planning activities including the creation or updates to URS, SDS and RTM documents, create, review and approve software validation documentation, create and execute qualification protocols and document reports; review and approve software test scripts and code reviews and review and approve internal and vendor software packages and test documentation.

Key Responsibilities:

• Develop complex subject matter expertise on Quality Assurance best practices and assists in the review of policies that may impact organizational objectives.

• Contribute to the design of processes for routine data collection, analysis, and reporting to ensure the continuous improvement of the quality management system.

• Design systems to collect and provide feedback to ensure continuous improvement of the quality management system.

• Implement processes to ensure the internal organization's alignment with overall quality priorities.

• Help establish formal escalation processes to surface issues of product quality, regulatory compliance, and quality systems.

• Deliver research related to regulatory changes, external trends, and strategy.

• Coach junior colleagues in techniques, processes, and responsibilities.

• Understand and apply Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.

Qualifications

Education:

• University/Bachelor’s or equivalent degree is required, preferably in Engineering, Computer Science or a related technical field.

Experience and Skills:

Required:

• Minimum of two to four (2-4) years of experience in a regulated environment and working knowledge of the following:

• FDA and European medical device regulations (QSR and ISO).

• Software validation requirements for software used in the production of medical devices and software used to support the Quality System.

• GAMP5 and SDLC.

• Regulations for electronic records, electronic signatures, and data integrity.

• Experience with change management and a strength with technical writing.

• Experience with SCADA and/or Manufacturing Execution Systems (MES) and experience working in manufacturing/operations.

• Proficient in Microsoft Excel & PowerPoint

Preferred:

• Medical device process validation experience.

• Experience in Quality Auditing and notified body inspections.

• Experience in Quality Systems process development, support, integration or enhancement.

• Experience with training or coaching others.

• Software Quality Engineer certification (CSQE) or Quality Engineer certification (CQE).

Other:

• This position will require up to 10% travel (international and domestic).

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 .

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.

Primary Location NA-US-Florida-Jacksonville

Organization Johnson & Johnson Vision Care, Inc. (6094)

Relocation Eligible: No

Travel Yes, 10 % of the Time

Job Function Quality Assurance

Req ID: 2406200957W