Quality Engineer II
Johnson & Johnson Innovative Medicine
Summary
Develop, apply, revise and maintain quality standards for processing materials/products into partially or finished products.
Job description
Design and implement methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products, components, sub-assemblies and/or production equipment.
Support manufacturing and work cross-functionally to resolve technical problems.
Participate in decisions on scope of work, risk management, design changes, process improvements, material disposition, and implementation of revised specifications.
Process, investigate, and complete customer complaints.
Prepare documentation for inspection/testing procedures, development studies, validation protocols and reports, quality plans, product defect investigations and inspection plans.
Assess if components, sub-assemblies, and products meet specification and can initiate, investigate, and resolve non-conformances by working in conjunction with a multidisciplinary team.
Participate in developing the risk management documentation including (Hazard assessment, design trace matrix development, DV&V testing, and FMEA).
Practice company safety, quality policies and procedures and participate in internal/external audits.
Requirements
- Bachelor's degree in Bioengineering, Biomedical Engineering or related field
- 2 years of experience in the job offered or in a Quality Engineer II-related occupation
- Experience in medical device industry
- Performing failure/Product Non-conformance investigations
- Production line support including non-conformance investigation and product disposition, supporting process changes and process validation activities including IQ, OQ, and PQ
- Technical writing skills for investigations, design and process verification and validation protocols and reports
- Developing risk management documentation including plans, hazard assessment, design trace matrix development, DV&V testing, and FMEA
- Conducting statistical analysis using minitab or equivalent tools for process capability and data normality assessments, analysis of variance, and hypothesis testing, determining appropriate sample sizes, tolerance interval assessments for variable and attribute data, design of experiment (DOE), and variable and attribute sampling plan applications
- ISO, ASTM, and FDA standards for quality within the medical device industry
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) savings plan
- Pension plan
- Long-term incentive program
- Vacation
- Sick time
- Holiday pay
- Parental leave
- Bereavement leave
- Caregiver leave
- Volunteer leave
- Military spouse time-off
Company overview
Johnson & Johnson Innovative Medicine is the pharmaceutical division of Johnson & Johnson, leading the way in medical innovation with a relentless focus on bringing transformational treatments to patients worldwide. The company applies rigorous science and compassion to address the most complex diseases of our time, developing groundbreaking medicines across key therapeutic areas including oncology, immunology, neuroscience, and cardiopulmonary medicine. With deep expertise and global reach, Johnson & Johnson Innovative Medicine reimagines how devastating diseases are treated and cured, delivering hope and better care for millions of patients and their families. The organization pioneers the path from laboratory research to clinical application, championing patients every step of the way while maintaining an unwavering commitment to scientific excellence and patient-centered innovation.