Sr. Quality Engineer

Locations: Danvers, MA and Woburn, MA. This role supports both sites.

About the role

As part of our "Patients First!" culture, you will play a crucial role in ensuring that high standards of product quality, compliance, and patient safety are maintained in the manufacturing of life-saving medical devices. This individual will be a member of the Quality organization, primarily supporting operations at the Danvers, MA site, with additional support for the Woburn, MA site. The Sr. Quality Engineer will provide Quality Engineering support across manufacturing and quality operations, including areas such as production, incoming inspection, nonconformance management, equipment and calibration, process validation, and other Quality functions as business needs and priorities require. The successful candidate must be comfortable working across functional boundaries and adapting responsibilities to support changing operational and Quality priorities.

Responsibilities

• Develop, modify, apply, and maintain quality evaluation and control systems/protocols
• Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment
• Design and analyze inspection and testing processes, mechanisms, and equipment
• Conduct quality assurance tests and perform statistical analysis to assess the level of control and manage product quality risks
• Undertake root cause analysis of incidents requiring corrective action
• Document production nonconformity, conduct investigation, assess product risk, recommend disposition in collaboration with other members of MRB
• Define and implement action plans and effectiveness monitoring for CAPA originated from internal/external audits
• Coach team members regarding any Quality Engineering non-conformance, subsequent corrective, and preventive actions, by documenting, investigating, and conducting root cause analysis, and successfully implementing corrective actions
• Ensure timely escalation of any Quality Engineering issues or concerns to the next management level
• Identify, under limited supervision, any Quality Engineering non-conformance, subsequent corrective, and preventive actions, by documenting, investigating, and conducting root cause analysis, and successfully implementing corrective actions
• Support process validations/revalidation on current and new processes (IQ, OQ, PQ)
• Support incoming inspection department as needed
• Collaborate with equipment department for PM and calibration procedural updates; support for non-conformities from failed calibration, etc.

Requirements

• Bachelor's degree in Engineering or a related technical field
• 2–4 years of relevant Quality Engineering or related experience
• Solid understanding of IQ, OQ, PQ validation processes and GMP compliance
• Proven track record to work independently and manage multiple tasks effectively
• Excellent problem-solving skills and a proactive approach to challenges
• Strong communication skills, with the ability to mentor and lead teams effectively

Preferred qualifications

• Working knowledge of SAP
• ASQ Certified Quality Engineer (CQE)
• Knowledge of electrical systems, schematic drawing, and IPC 610
• Experience in medical device industry working under FDA regulations (21 CFR Part 820), ISO 13485, and EU MDR
• ISO 13485 Internal audit certificate

Additional information

• This role is eligible for immigration sponsorship, if required
• Relocation support is not available for this position
• Understands and applies Johnson & Johnson's Credo and Leadership Imperatives in day-to-day interactions with team

Pay

Anticipated base pay range: $79,000.00 – $127,650.00

Benefits

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 (Colorado residents: 48 hours; Washington residents: 56 hours)
• 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 period
• Volunteer Leave – 32 hours per calendar year (10 days)
• Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, see https://www.careers.jnj.com/employee-benefits.