Staff Quality Systems Specialist

Staff Quality Systems Specialist – 2406213013W

Description

Johnson & Johnson Abiomed is recruiting for a Staff Quality Systems Specialist . This position can be based in Danvers, Halethorpe . Remote work options may be considered on a case-by-case basis and if approved by the company.

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.

At Johnson & Johnson MedTech (MT) Companies, we use technology and the power of collaboration to discover new ways to prevent and overcome the world’s most significant healthcare challenges. MedTech Quality Systems organization leverages modern technology solutions, data, real-world insights, and creative minds to support development of life-changing products. Were disrupting traditional way of working by infusing our existing best practice with transformative ideas to help MT businesses thrive throughout every stage product lifecycle and deliver the highest quality experiences for our patients, consumers, and customers in an increasingly connected and personalized world.

The Staff Quality Systems Specialist will be responsible to lead the monitoring, assessment, and implementation of standards and regulations. The role involves collaborating with cross-functional teams, conducting gap assessments, documenting procedures, and maintaining compliance records.

Key Responsibilities :

Manage the external standards and regulations gap assessment and gap closure activities.

Identify SMEs for new and revised external standards and regulations.

Assign, review, and approve external standards and regulations assessments.

Assist SMEs with the external standards and regulations assessment process.

Serve as lead SME in completing gap assessments for Quality System related external standards and regulations.

Track the status of SME assignments relative to due dates, providing reminders and assisting with extensions, where appropriate.

Monitor external standards and regulations for changes.

Maintain the Master Standards and Regulations List for Abiomed.

Serve as a local SME on the standards and regulations process for Abiomed in audits.

Maintain lists in external standards and regulations monitoring services.

Prepare standards and regulations content for Quality Systems Management Review and present at the meeting, if requested.

Assist with sourcing, assisting, and tracking Abiomed SMEs for J&J internal standards.

Qualifications

Education:

University/Bachelor’s degree is required; a degree concentration in Math, Science, Business, Engineering, or other relevant subject area will be an asset.

Experience and Skills

Required:

Minimum of four to six (4-6) years of related experience.

Experience in Quality Systems, Quality Engineering, Quality Assurance, or other technical work experience.

Minimum of five (5) years of experience in an FDA regulated industry.

Ability to work independently and as part of a team.

Preferred:

Working knowledge of 21 CFR Part 820, 21 CFR 806, ISO 13485, ISO 9001 and familiarity with ISO 14971.

Broad-based technical knowledge and experience to work effectively with others in diverse areas of business (Operations, Quality, R&D, R.A., Engineering).

Ability to effectively prioritize and manage multiple activities and responsibilities.

Outstanding business and technical communication skills (verbal, written, presentation).

American Society for Quality (ASQ) credentials.

Other:

Up to 10% travel, domestic and internationally required.

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-4887-Danvers

Other Locations NA-United States, NA-US-Massachusetts-Woburn

Organization ABIOMED Inc.(6942)

Relocation Eligible: No

Travel Yes, 10 % of the Time

Job Function Quality Systems

Req ID: 2406213013W