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Staff Quality Systems Engineer - 2406194569W

Description

Johnson & Johnson is currently seeking a Staff Quality Systems Engineer to join our Abiomed Team located in Danvers, Massachusetts. We are open to remote candidates for this 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.

The Staff Quality Systems Engineer , will have responsibility for the end-to-end process related to product issue escalations through the decision-making framework of quality review boards incorporating worldwide standards and regulations. Additionally, the position will have responsibilities for identifying improvement trends and presenting opportunities to management.

Duties and Responsibilities

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position will be responsible for:

• Train, coach and mentor Abiomed teams in the execution of the Product Issue Escalation process to ensure compliance with MD and J&J standards.

• Facilitate teams of multi-functional SMEs to execute root cause investigation and bounding, to assess regulatory and medical safety impact and review associated quality system records and risk documentation

• Lead weekly reviews on open investigations with SMEs and representatives of the risk management board (RMB), drive timely actions and updates, facilitate identification of higher risk issues as early as possible, communicate to management on high-risk safety, quality or compliance issues

• Lead RMB and Quality Review Board (QRB) meetings; prepare presentations of each issue and guide quorum to a final vote; complete records and meeting minutes in a timely and compliant manner, route records for approvals

• Liaison with field action team to ensure transition of QRB actions and documentation

• Support Data Requests for post market surveillance, regulatory registrations, etc.

• Support internal and external audits in preparation activities, backroom and front room roles

• Complete special assignments across Abiomed initiatives as requested

• Support driving key process metrics for Product Issue Escalation, communicate status and identify opportunities for process improvements

• Manage product issue escalation files, lead in product problem resolution as part of follow-up from QRB and CAPA.

• Responsible to review any actions (such as: NC, SCAR, Corrective Actions, etc.) resulted from Product Issue Escalations to ensure these are aligned with requirements identified during the Risk Management or Quality Review Boards.

• Thrives in an environment that embraces teamwork, change, risk-based decision-making and flexibility.

• Communicates effectively at all levels within Quality as well as business partners within departments such as Medical Safety, R&D, Regulatory, Supplier Quality, Manufacturing, and Marketing.

• Provide support to internal and external audit processes. Serve as SME in responsible areas for internal and external audits.

• Responsible for communicating business related issues or opportunities to next management level.

• Execute in technology platform (EtQ) supporting the product issue escalation and quality review board, to ensure compliance to regulations and standards and effective internal process flow.

Qualifications

Experience and Education

• BS degree in scientific and/or engineering discipline or equivalent

• Minimum of 8 years of related work experience

• 5 years of related experience in Quality Assurance within Medical Device, Diagnostic, Pharmaceutical or other regulated industry

Required Knowledge, Skills, Abilities, Certification/Licenses and Affiliations

• Experience working with FDA Quality System Regulation and ISO 13485 Standard.

• The ability to work independently and lead a multi-functional team is required

• Excellent interpersonal relations, negotiation, decision-making and communication skills that foster conflict resolution to technical situations are desired.

• Excellent interpersonal skills, negotiation and influencing skills. Strong oral and written communications skills with ability to speak to broad, non-technical audiences that are both internal and external personnel. Skilled at preparing executive briefings and broad communications.

• Skilled at refining technical information to accommodate broader audiences.

• Experience with preparing and reviewing technical documentation.

• Ability to prepare and perform audit reviews of quality system documentation for compliance readiness

• Ability to work in fast paced environment with rapidly shifting priorities while maintaining high attention to detail.

• Experience working with product risk management and applying analytical and problem-solving skills.

• Ability to make solid decisions that will effectively support the business and company policies.

• Advanced skills in Microsoft Office software, including PowerPoint, is required.

The anticipated base pay range for this position is $90,000 - $144,900

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.

§ 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

Additional information can be found through the link below.

https://www.careers.jnj.com/employee-benefits

• This job posting is anticipated to close on [July 5th, 2024]. 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.

Primary Location NA-United States

Organization ABIOMED Inc.(6942)

Relocation Eligible: No

Travel Yes, 10 % of the Time

Job Function Quality Systems

Req ID: 2406194569W