Johnson & Johnson MedTech · 6 hours ago
Senior Quality Engineer
Raynham, MA
Full-time
Onsite
Mid, Senior Level
$77K/yr - $124K/yr
4+ years expJohnson & Johnson MedTech is a leader in healthcare innovation focused on developing smarter, less invasive treatments. The Senior Quality Engineer will provide quality assurance leadership, manage contract manufacturing sites, conduct audits, and support quality improvement initiatives to ensure compliance with industry standards.
Hospital & Health Care
Responsibilities
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 quality
Supports 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
Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process
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 plans
Assess 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 QSRs
Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements
Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process
Qualification
Required
University/bachelor's degree or Equivalent
4 to 6 years of relevant work experience and in the medical device environment is required
NR, CAPA, and audit experience is required
Strong trending and data analysis skills is required
Troubleshooting expertise is required
Analyze/review effectiveness of preventive and corrective actions. Review RCA investigations according to an established process
Preferred
Process excellence/Six Sigma certification or equivalent
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 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
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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