Johnson & Johnson Careers
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Project Manager, Supplier Quality Compliance
Cincinnati, Ohio; Irvine, California; Raynham, Massachusetts; Juarez, Mexico; Albuquerque, New Mexico; Jacksonville, Florida; Warsaw, Indiana; West Chester, Pennsylvania
Requisition ID: 00001CKY
Ethicon Surgical Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Project Manager, Supplier Quality Compliance, this role can be based in any MD location in the US (West Chester- PA; Raynham- MA; Irvine- CA, Warsaw- IN; Jacksonville- FL) but preferably any Ethicon Endo Surgery Operation location, in Cincinnati- OH, Albuquerque-NM; or Juarez- MX.
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 electiveness 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. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal.
You, the Project Manager, Supplier Quality Compliance will ensure effective supplier quality audit program. Ensure effective FDA Readiness program for key critical suppliers. Accountable for the absence of significant quality issues and regulatory compliance actions by government agencies. Accountable for the proactive identification and alerting of quality issues in time to resolve potential adverse effects to the customer, company image/reputation and/or the business. Accountable for effective regulatory agency inspections.
DUTIES & RESPONSIBILITIES
- Develop and execute organizational and operational policies for the franchise wide quality system supplier quality audit program.
- Manage external auditors/contract auditors.
- Make decisions regarding work processes or operational plans and schedules in order to achieve department objectives
- Assess proposed regulations and communicate new requirements to the organization
- Alert organization to existing and potential problems and risks.
- Provide compliance and quality consultation services.
- Collaborate with functional department to establish effective CAPAs.
- Conduct supplier audits and gap assessments in support of the supplier quality audit program and FDA readiness.
- Ensures audit reports are issued within the prescribed time frame.
- Monitor supplier quality audit program performance through the use of trending and metrics.
- Serve as a consultant, making recommendations and corrective actions, which are required regarding audit results, and compliance to written procedures or applicable government regulations.
- Maintain files containing audit reports, re audit reports, and audit responses, and pertinent corrective action follow-up for audits conducted in support of the supplier quality audit program.
- Other responsibilities as required or assigned by manager.
- Bachelor’s degree is required, a concentration in scientific or technical field is preferred.
- Minimum of 8 years’ experience in quality compliance with recent experience in a highly regulated industry is required, experience medical device, diagnostics or pharmaceutical industry is strongly preferred.
- Certified quality auditor and or lead auditor required
Other Skills and Abilities
- Progressive quality systems experience, quality control, quality assurance experience, including hands on advanced quality systems compliance.
- Strong leadership ability, interpersonal, communication, and influencing skills.
- Demonstrated compliance experience in domestic and international medical device and combination product quality systems.
- Ability to analyze, balance, and prioritize risk.
- Good written and oral English communication skills.
- Ability to read, analyze and interpret scientific and technical journals, and legal documents.
- Significant understanding in FDA CFR Part 820, Part 11, and ISO 13485 regulations is required. Ability to select, manage and direct a team during an audit.
- Ability to respond to common inquiries, regulatory agencies, or members of the business community.
- Strong statistical skills and manufacturing process understanding.
- Ability to lead a team through a root cause analysis problem.
- Ability to effectively present information to top management, public groups, and/or boards of directors.
- Engages in constructive conflict.
- High tolerance for ambiguity in a complex environment.
- Makes the complex clear and easily understood by others.
- The position will require approximately 30-40% travel both domestically and internationally.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
North America-United States-Indiana-Warsaw, Latin America-Mexico-Chihuahua-Juarez, North America-United States-Florida-Jacksonville, North America-United States-Pennsylvania-West Chester, North America-United States-California-Irvine, North America-United States-Massachusetts-Raynham, North America-United States-New Mexico-Albuquerque
Ethicon Endo Surgery Inc (6041)