Johnson & Johnson is currently seeking an Experienced Technician Quality Review Specialist to join our team located in Danvers, MA.

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/.

A pre-identified internal candidate is being considered for this role.

Job summary:

Abiomed, part of Johnson & Johnson MedTech, is recruiting for a Quality Review Specialist located in Danvers, MA. In this role, you will have the unique opportunity to contribute to the manufacturing of life-saving medical devices. As part of our "Patients First!" culture, you will play a crucial role in ensuring the highest quality standards are met to save lives and recover hearts. Following established procedures to verify/proof and edit product labeling and packaging graphics.

Key responsibilities:

• Perform reviews of Device History Records (DHR) on the production floor for compliance to procedures, including good documentation practices (GDP), documented test results within specification, and ensuring completeness of the record

• Advising personnel on good documentation practices (GDP)

• Perform review or inspection of critical manufacturing process steps to specified requirements such as in process inspections, clean room behavior and adherence to defined process parameters by performing walk-throughs of production and support areas

• Support non-conformance investigations, including cause analysis and documenting findings

• Control and maintain current version of Device Master Documents on the production floor

• Review, scan, maintain and archive Device History Records

• Participate in Internal and External Quality Audits and support the audit program as needed

Qualifications

Qualifications:

Education:

High School or equivalent or associate degree.

Experience and Skills:

Required:

• 0 -2 yrs related work experience

• Medical device experience preferred or other highly regulated environment

• Ability to stay organized, pays attention to important details, and effectively handles multiple tasks and priorities.

• Ability to communicate ideas and information clearly, effectively, and frequently (oral and written)

• Quality Assurance experience & knowledge of GMP desired

• Working knowledge of SAP desired.

Additional Information:

The anticipated base pay range for this position is $43,400.00 to $59,400.00 This position is overtime eligible.

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:

• 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

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.

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

A pre-identified internal candidate is being considered for this role.

This job posting is anticipated to close on February 21, 2025. 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.