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Supplier Quality Compliance, Project Manager Job

Company Name:
J&J Family of Companies
Johnson & Johnson companies are equal opportunity employers.
Supplier Quality Compliance, Project Manager-8949140421
Description
Ethicon Surgical Care, a member of the Johnson & Johnson Family of Companies, is recruiting a Supplier Quality Compliance, Project Manager. The preferred location for this position is Somerville, NJ, however this position can also be located at any other Johnson & Johnson MD&D; location globally.
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.
The role of the SQC Project Manager will ensure an effective supplier quality audit program and an effective FDA Readiness program for key critical suppliers. The individual will be accountable for the absence of significant quality issues and regulatory compliance actions by government agencies. The SQC Project Manager will be accountable for the proactive identification and alerting of quality issues in time to resolve, along with ensuring effective regulatory agency inspections.
The SQC Project Manager will develop and execute organizational and operational policies for the franchise wide quality system supplier quality audit program. The individual will manage external auditors/contract auditors and make decisions regarding work processes or operational plans and schedules in order to achieve department objectives. He/she will assess proposed regulations and communicate new requirements to the organization. The SQC Project Manager will alert the organization to existing and potential problems and risks, as well as provide compliance and quality consultation services. This individual will also lead the coordination of the Procurement Management Review for the franchise. The individual will collaborate with functional department to establish effective CAPAs and conduct supplier audits and gap assessments in support of the supplier quality audit program and FDA Readiness. He/she will monitor supplier quality audit program performance through the use of departmental metrics and implement necessary steps to ensure on-going health of program. The position will serve as a consultant, making recommendations and corrective actions, which are required regarding audit results, and compliance to written procedures or applicable government. The individual with 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. The SQC Project Manager will review audit responses and assist with required training in response to audit findings and other GMP/ISO/JPAL related issues as needed. He/she will provide advice and guidance to less seasoned Quality System Auditors. The role will also maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meetings. This individual will also lead MD&D; level Supplier Quality Compliance projects.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit and stand for long periods of time. Specific vision abilities required by this job include close vision. While performing the duties of this job, the employee occasionally works near moving mechanical parts and is occasionally exposed to fumes or airborne particles and risk of electrical shock.
Qualifications
To be considered for the role a minimum of a Bachelors Degree in a scientific or technical field is required. A minimum of 5 years experience in a quality function in Medical Devices, Pharmaceutical, Biotech, or FDA regulated healthcare industries is required. Certified quality auditor and/or lead auditor is preferred. Experience with quality systems and compliance is required. Supplier related experience is preferred. A strong leadership ability, interpersonal, communication and influencing skills required. Demonstrated compliance experience in domestic and international medical device and combination product quality systems is preferred. Knowledge of FDA regulations is required. The ability to select, manage and direct a team during an audit is preferred. Strong statistical skills and manufacturing process understanding is preferred.
The ability to analyze, balance and prioritize risk is important for this role. Ability to read, analyze and interpret scientific and technical journals, financial reports and legal documents. Ability to respond to common inquiries, regulatory agencies, or members of the business community. Ability to lead a team through in conducting a root cause analysis investigation is required. Ability to present information to top management, public groups and/or boards of directors. Skilled in contentious situations. High tolerance for ambiguity in a complex environment. Makes the complex clear and easily understood by others.
The preferred location for this position is Somerville, NJ, however this position can be located at any MD&D; location globally. Up to approximately 40% domestic and international travel may be required.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
J2W:BIO
J2W:NSJ
J2W:MZ
J2W:DICE
Primary Location: North America-United States-New Jersey-Somerville
Organization: Ethicon Inc. (6045)
Job Function: Compliance
Travel: Yes, 50 % of the Time
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
Req ID: 8949140421
Date: Thu, 08 05 2014 00:00:00 GMT
Country: US
State: NJ
City: Somerville
Postal Code: 08876
Locale: en_US

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