The Ethicon Surgical Care business, a member of the Johnson & Johnson Family of Companies, is currently recruiting for a Compliance Manager. This position will be based in Cincinnati, OH or Somerville, NJ.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market-leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.
The Compliance Manager, has the following principal responsibilities and duties:
• Responsible for internal audits at HQ/franchise operations. Ensure all franchise operations internal audits are conducted on time.
• Define approach and governance for HQ/franchise quality system internal audit program including training of auditors
• Collect and report metrics in support of internal compliance for HQ/franchise operations.
• Alert organization and senior management on existing and potential problems and risks and provide potential solutions. Provide compliance consultation as needed.
• Collaborate with functional departments to establish effective corrective and preventive actions.
• Assist in formulating regulatory policies and procedures to be followed by company personnel in compliance with local, state, and federal regulations through the development of Franchise documents and Standard Operating Procedures.
• Review and provide input to regulatory agency submissions as needed.
• Accountable to assure that franchise sites are inspection ready and that franchise senior management is alerted to potential quality system compliance issues in time to mitigate or prevent. Qualifications
• A minimum of Bachelor’s Degree in scientific or technical field.
• A minimum of 8 years of related experience is required, with a minimum of 6 years in a Quality function.
• Experience of auditing in the medical device, pharmaceutical or biopharmaceutical is required.
• Experience interacting with FDA or ISO auditors and influencing Quality regulations and standards is preferred.
• Experience in a highly matrixed global environment is a plus.
• Knowledge of interpretation and application of 21CFR 210, 211, 800’s and 600’s, QSR, MDD, and ISO 13485 is preferred.
• Certified quality (lead) auditor preferred.
• ASQ certification (CQE, CQA & PE) is preferred.
• This position may require up to 30 % travel international and domestic depending on location of the role and will be based in Cincinnati, OH or Somerville, NJ.
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J2W: LI NAPrimary Location
United States-Ohio-CincinnatiOther Locations
North America-United States-New Jersey-SomervilleOrganization
Ethicon Endo Surgery Inc (6041)Job Function