Sr Tech Quality Review Specialist - Johnson and Johnson

Johnson & Johnson is currently seeking a Senior Technician Quality Review Specialist to join our Abiomed. 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/.

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.

Job summary:

Abiomed, part of Johnson & Johnson MedTech, is recruiting for a Sr. Tech Quality 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 neededQUALIFICATIONS:

Education:

• High School or equivalent or Associate Degree.

Experience and Skills:

Required:

• 2 - 4 yrs related work experience

• Medical device experience preferred or other highly regulated environment

• Shows 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 Mastering Complexity.

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.