Johnson & Johnson MedTech · 1 hour ago
Senior Supplier Quality Engineer
Cincinnati, OH
Full-time
Onsite
Mid, Senior Level
$79K/yr - $128K/yr
2+ years expJohnson & Johnson MedTech is a leader in healthcare innovation, dedicated to improving health through advanced treatments. The Senior Supplier Quality Engineer will be responsible for overseeing supplier-related quality engineering activities to support new product development and ongoing manufacturing, ensuring compliance with quality standards and continuous improvement.
Hospital & Health Care
Responsibilities
Issues resolution with suppliers – investigating challenging issues with significant business impact
Developing and maintaining suppliers – executing Supplier Reviews, audit related activities and deep dive Technical Assessments at suppliers
Development/negotiation of Quality Agreements with suppliers
Changing the way we do business – continuously improving our policies and procedures
Supplier process changes – assessing, documenting, validating, and leading or approving significant changes in supplier processes (including component approval activities)
Stabilizing new products at suppliers – working with NPD and suppliers to ensure a smooth product launch from a supplier perspective, through both pre- and post-launch activities
The technical liaison, as needed, between product development, manufacturing, external manufacturers & suppliers
Provide leadership in design & implementation of world-class quality engineering to support the entire product life cycle with focus on quality engineering activities such as root cause analysis, corrective/preventive action, risk management, analytics/statistical techniques, verification & validation, and design control across the lifecycle of the product
Provide leadership and technical expertise to ensure supplier conformance to applicable ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) requirements
Qualification
Required
A minimum of a Bachelor's degree is required
A minimum of 2 years Quality/Manufacturing experience or related experience is required
It is required to be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Operations, Medical Affairs, Compliance, Manufacturing, etc
Strong root cause analysis skills are required
Preferred
A degree concentration in Engineering, Life Science, Physical Science and/or related is preferred
An advanced degree is preferred
Experience in the medical device, pharmaceutical or other highly regulated industry is preferred
Knowledge of ISO and/or cGMP regulations is preferred
Experience in a FDA regulated environment is preferred
An ASQ certification (CQE, CQM, CRE or CQA) is preferred
Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is preferred
Basic knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is preferred
Auditing experience is preferred
Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and effects analyses is strongly preferred
Benefits
Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))
This position is eligible to participate in the Company’s long-term incentive program
Vacation –120 hours per calendar year
Sick 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 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
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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
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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