Senior Lifecycle Quality Engineer (Medical Devices)

Location: Cincinnati, Ohio, United States of America; onsite role with up to 10% domestic and international travel

Salary: $92,000–$148,350 per year

Company

Johnson & Johnson MedTech develops healthcare and medical device solutions across Innovative Medicine and MedTech.

What you will do

• Lead quality engineering activities across the full product lifecycle, including reliability, risk management, requirements management, verification and validation, analytics, and design control.
• Support product teams, contract manufacturers, suppliers, and manufacturing operations with quality system design, audits, compliance assessments, and process improvement.
• Review and approve engineering documentation, technical reports, work instructions, validations, new product releases, and design changes.
• Investigate product and process complaints using data analysis, root cause methods, continuous improvement, and corrective and preventive actions.
• Oversee quality system audits and measurement systems that monitor quality and reliability performance.
• Perform or oversee design verification testing, test method development, and inspection of prototypes, tools, and fixtures.

Requirements

• Bachelor’s degree in engineering or a relevant science or technical field; Mechanical, Electrical, or Biomedical Engineering is preferred.
• At least 4 years of work experience, preferably in a regulated industry.
• Strong analytical problem-solving skills, including root cause investigations and corrective action effectiveness assessments.
• Sound statistical knowledge covering DOE, sampling, regression, reliability, FMEA, and hypothesis testing.
• Experience with risk management, ISO 14971, ISO 13485, Gage R&R, reliability, project management, and multiple simultaneous priorities is strongly preferred.
• Knowledge of regulatory compliance, GMP, MDD, 510(k), PMA, ISO, QSR, MDSAP, and auditing standards is preferred.

Nice to have

• Advanced Quality Systems experience.
• ASQ certification such as CQE, CQM, CRE, or CQA.
• Six Sigma or Process Excellence certification.
• Technical understanding of manufacturing equipment and processes.
• Experience providing training or mentoring in statistics and quality methods.

Culture & Benefits

• Inclusive work environment guided by the J&J Credo.
• Participation in pension and 401(k) savings plans.
• Eligibility for the long-term incentive program.
• Paid vacation, sick time, holidays, personal and family time, parental leave, caregiver leave, bereavement leave, volunteer leave, and military spouse time off.