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Johnson & Johnson · 2 days ago
Senior Director, Quality Engineering
West Chester, PA
Full-time
Onsite
Director
$187K/yr - $322K/yr
12+ years exp
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Responsibilities
Will be a member of DPS TECA & Mitek Sports Platform Operating Committee and will provide the quality strategic vision for the organization.
Will provide guidance and coaching to all levels within the Quality organization and Quality leadership for the business.
Will partner with R&D, Supply Chain, Regulatory & Marketing to assure all LCM/NPI engineering and quality deliverables are met within quality, cost, and schedule targets.
Will partner with R&D, Supply Chain, Regulatory & Marketing to assure there is appropriate execution of risk management, design controls and process validation for new and existing products.
Will manage overall quality budget, ensuring effective allocation of resources and investments to achieve quality objectives.
Will be accountable for quality metrics to identify systemic product and process issues assuring appropriate investigation, correction, and corrective and preventive action when needed.
Will be responsible for the Synthes and Mitek Quality Management Review.
Will support Quality related activities for product issue escalation, investigations (PIE/PIA) and QRB.
Will partner with Supplier Quality and Manufacturing, to ensure Quality strategy is aligned with J&J Med Tech Quality strategies.
Will host FDA/TUV/BSI and other Health Authority audits.
Responsible for communicating business related issues or opportunities to next management level.
Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Performs other duties assigned as needed.
Qualification
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Required
A minimum of a bachelors degree in a technical field is required.
A minimum of 12 years quality assurance management experience in medical devices is required.
Strong knowledge of design control requirements is required.
Direct experience leading Notified Body/FDA audits is required. Strong knowledge of FDA and EU regulatory compliance for Medical Devices is required.
Previous experience managing multiple projects is a required.
Experience of developing concise and audience-focused communications, both written and for presentations is required.
25% travel is required.
Preferred
Previous Biomaterials experience is preferred.
Experience in pharmaceuticals or Biologics is preferred.
Benefits
Medical Insurance
Dental Insurance
Vision Insurance
Life Insurance
Short- and Long-Term Disability Insurance
Business Accident Insurance
Group Legal Insurance
Pension Plan
401(k) Savings Plan
Long-Term Incentive Program
Paid Time Off (Vacation, Sick Time, Holidays, Personal and Family Time)
Company
Johnson & Johnson
Johnson & Johnson develops medical devices, pharmaceuticals, and consumer packaged goods.
10,001+ employees
H1B Sponsorship
Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (43)
2022 (55)
2021 (40)
2020 (30)
Funding
Current Stage
Public CompanyTotal Funding
unknown1978-01-13IPO· nyse:JNJ
Leadership Team
Alex Gorsky
Chairman & CEO
Dominic J. Caruso
Vice President, Finance and Chief Financial Officer
Recent News
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2024-05-29
2024-05-26
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2024-05-24
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