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Job Function:
Supply Chain EngineeringJob Sub Function:
Quality EngineeringJob Category:
Scientific/TechnologyAll Job Posting Locations:
Danvers, Massachusetts, United States of AmericaJob Description:
Abiomed is recruiting for a Sr Manufacturing Quality Engineer located in Danvers, MA.
About MedTech
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
At Abiomed, part of Johnson & Johnson, we are currently seeking a highly skilled and motivated individual to join our team as a Sr. Manufacturing Quality Engineer to support our facilities expansion. In this role, you will have the unique opportunity to contribute to manufacturing 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.
Key Responsibilities:
- Provide quality engineering support in the development and manufacturing of new and existing equipment and facilities
- Ensure compliance of manufacturing processes and areas to all applicable quality system regulations
- Lead Quality reporting such as, key performance metrics, goals, and objectives for capital products
- Lead and support activities related to the Material Review Board for facilities
- Lead non-conformance investigations, including cause analysis, documenting findings, and approving material dispositions. Promptly address any quality concerns through corrections, corrective/preventative actions, and Escalations for any facility and environmental non conformances.
- Monitor and analyze production information to support risk management and provide direction for corrective and preventive actions (CAPA) and/or process improvement activities for facilities
- Validate manufacturing processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), Test method validations (TMV) for facility expansion
- Collaborate with manufacturing engineering to ensure the implementation of necessary process controls and validations, while adhering to established guidelines (GMP)
- Support process optimization using design of experiments (DOE) and retrospective data analysis to understand and minimize sources of process variation affecting products. Identify key process input variables and key process output variables
- Support Quality Management System (process development, creating and editing new and existing SOPs). Support internal and external auditing requirements in manufacturing for capital products
Qualifications
Education:
- A Bachelor's or equivalent degree in a relevant Engineering field is required
Experience and Skills:
Required:
- 2-4 years of experience in Quality Assurance/Quality Engineering (QA/QE) in the medical device field
- Experience with formal problem-solving methodologies and deductive skills
- Good understanding of FDA QSRs, ISO13485, ISO14971
- Experience with handling non-conforming material and assemblies, including root cause investigations
- Experienced in qualification of production equipment and validation of production processes
Preferred:
- Experience with facility moves and implementation of new equipment in facilities
- Blackbelt or lean certified
Other:
- Up to 10% domestic and international travel is required
- Role is on site at our Danvers, MA facility
Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Analytical Reasoning, Coaching, Customer Centricity, Data Savvy, Document Management, Financial Competence, Good Automated Manufacturing Practice (GAMP), Lean Supply Chain Management, Process Improvements, Quality Control Testing, Quality Services, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically SavvyThe anticipated base pay range for this position is :
$79,000.00 - $127,650.00Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
Skills Required
- Bachelor's degree in a relevant Engineering field
- 2-4 years QA/QE experience in the medical device field
- Understanding of FDA QSRs, ISO 13485, ISO 14971
- Experience handling non-conforming material and assemblies, including root cause investigations
- Experience qualifying production equipment and validating production processes (IQ/OQ/PQ, TMV)
- Experience with formal problem-solving methodologies and deductive skills
- On-site work at Danvers, MA facility
- Up to 10% domestic and international travel
- Experience with facility moves and new equipment implementation
- Blackbelt or Lean certification
- Familiarity with Good Automated Manufacturing Practice (GAMP) and QMS/SOP development
Johnson & Johnson Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.
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Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
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Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
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Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.
Johnson & Johnson Insights
What We Do
Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines
