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Senior Director, Quality Engineering
2 months ago
J&J Family of Companies Senior Director, Quality Engineering - Honolulu, Hawaii
Description
Medical Device Business Services Inc. is recruiting for a
Senior Director, Quality Engineering
to be located in various locations including West Chester, PA, Raynham, MA, Palm Beach Gardens, FL, Zuchwil, Switzerland, Leeds, England, Cork, Ireland, or a Johnson and Johnson site in the United States.
The Senior Director Quality Engineering will be accountable for the development, execution, and delivery of quality strategies for DPS TECA and Mitek Sports Medicine lifecycle management (LCM) and new product introduction (NPI) engineering activities.
Responsibilities:
Member of DPS TECA & Mitek Sports Platform Operating Committee providing quality strategic vision.
Provide guidance and coaching to all levels within the Quality organization.
Partner with R&D, Supply Chain, Regulatory & Marketing for LCM/NPI engineering and quality deliverables.
Manage quality budget and metrics for product and process issues.
Support Quality related activities for product issue escalation and investigations.
Partner with Supplier Quality and Manufacturing for Quality strategy alignment.
Host FDA/TUV/BSI and other Health Authority audits.
Communicate business-related issues or opportunities to the next management level.
Ensure compliance with regulations and Company guidelines.
Qualifications
Education:
Bachelor's degree in a technical field.
Experience and Skills:
Required:
Minimum 12 years quality assurance management experience in medical devices.
Strong knowledge of design control requirements.
Direct experience leading Notified Body/FDA audits.
Experience managing multiple projects.
Experience in developing concise communications.
Preferred:
Previous Biomaterials experience.
Experience in pharmaceuticals or Biologics.
Knowledge, Skills and Abilities:
Strong problem solver with ability to identify multiple solutions.
Effective presentation and communication skills.
Strong relationship builder and negotiator.
Highly motivated individual with excellent interpersonal skills.
Other:
25% travel required.
The anticipated base pay range for this position is $187,000 to $322,000.
For additional information on benefits and to apply, visit
here .
This job posting is anticipated to close on 7/22/24.
Primary Location:
NA-US-Pennsylvania-West Chester
Organization:
Medical Device Business Services, Inc (6029)
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