Senior Quality Engineer - Orthopedics

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 jnj.comAs guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.Job Function: Supply Chain EngineeringJob Sub Function: Quality EngineeringJob Category:Scientific/TechnologyAll Job Posting Locations:Raynham, Massachusetts, United States of AmericaJob Description:About MedTechFueled 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 We are searching for the best talent for a Senior Quality Engineer to be located in Raynham, MA.The Senior Quality Engineer provide an overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson and Johnson products. Also, conducts audits to good manufacturing practices, international organization for standardization and any other applicable standards.You will be responsible for:Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.Conduct benchmarking to develop more effective methods for improving qualitySupports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.Formulates and executes quality improvements.Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.Supports new product introduction as part of design transfer.Supports activities related to the Material Review Board.Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality.Represents as an Subject Matter Expert (SME)Support or leads in developing validation strategies.Approves IQ, OQ, PQ, TMV or Software Validation.Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.Develop, interpret and implement standard and non-standard sampling plansAssess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRsAssess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.Ensures effective quality strategies are created for the validation of test methods, process and design.QualificationsEducation: A minimum of a university/bachelor’s degree in Engineering or Equivalent is required.Required:A minimum of 4 years of related work experience.Experience in Medical Device or regulated industry.NR, CAPA, Audit Experience.Strong Trending and data analysis skills.Troubleshooting expertise.Preferred: Process Excellence / Six Sigma Certification or equivalent certification.Additive manufacturing experienceOther: This position may require up to 10% of domestic and/or international travel.Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.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 , internal employees contact AskGS to be directed to your accommodation resource.#LI-Onsite 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 yearSick 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 yearHoliday pay, including Floating Holidays –13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar yearParental Leave – 480 hours within one year of the birth/adoption/foster care of a childBereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar yearCaregiver Leave – 80 hours in a 52-week rolling period10 daysVolunteer Leave – 32 hours per calendar yearMilitary Spouse Time-Off – 80 hours per calendar yearFor additional general information on Company benefits, please go to: - Raynham, Massachusetts, United States of AmericaType: Full time