Massachusetts Veterans Jobs

Senior Quality Engineer, Product Escalation - 2406200158W

Description

DePuy Synthes, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Quality Engineer, Product Escalation, located in either: Raynham, MA, Warsaw, IN, West Chester, PA or Palm Beach Gardens, FL!

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 Senior Quality Engineer, Product Escalation will have responsibility for driving product quality issues through the decision-making framework of risk management boards and quality review boards.

What You Will Need To Succeed

To succeed in the role, you are structured, detailed, quality-conscious, and promote risk-based decision making. You are adaptable and solution oriented and are happy to come up with new insights. As a person, you are driven and proactive, have a good ability to work independently as well as collaborate with team members. The work requires that you are detailed, flexible and enjoy working according to set time targets. The pace of work can sometimes be high, and it is important that you can plan your work while at the same time be open and flexible for re-prioritization.

We believe our candidate has excellent communication, interpersonal, organizational and analytical skills. We are a dedicated team with different skills where everyone stands up for each other to build a positive atmosphere. We look forward to having you in our team!

Key Responsibilities:

In this role you will evaluate events and trends within the quality system to assure safety, efficacy, and quality of products throughout their lifecycle via Product Quality & Health Risk Evaluations.

• Facilitate teams of multi-functional SMEs to complete 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 manner, route records for approvals.

• Liaise 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 DPS and/or MedTech initiatives as requested.

Qualifications

Education:

• Bachelor’s degree or equivalent in Engineering, Computer Science or STEM (Science, Technology, Engineering, Math) related field.

Experience and Skills:

Required:

• A minimum of four (4) years of proven experience in a highly regulated environment is required.

• Experience with root cause investigations and associated bounding.

• Knowledge and experience with Microsoft Office software as well as intermediate to advanced software skills with Microsoft Excel and PowerPoint.

• Excellent problem-solving skills, self-motivated, able to work efficiently independently and in a team environment.

• Able to progress work forward in the face of ambiguity.

Preferred:

• Experience in the Medical Device Industry.

• Prior experience in ISO 13485 and/or QSR 820 FDA regulated environment.

• Quality Engineering/Design or Process Excellence/Lean Experience, ASQ or Six Sigma Certification, mechanical product knowledge.

• Experience in manufacturing and/or mechanical knowledge.

• Project management experience.

• Excellent interpersonal relations and decision-making skills that further conflict resolution to technical situations.

Other:

• This position is located in Raynham, MA; Warsaw, IN; West Chester, PA or Palm Beach Gardens, FL and may require up to 10% domestic or international travel.

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 (https://jnjc.taleo.net/enterprise/www.careers.jnj.com) .

Primary Location NA-US-Pennsylvania-West Chester

Other Locations NA-US-Indiana-Warsaw, NA-US-Florida-Palm Beach Gardens, NA-US-Massachusetts-Raynham

Organization Medical Device Business Services, Inc (6029)

Travel Yes, 10 % of the Time

Job Function Quality Systems

Req ID: 2406200158W