External Manufacturing & Supplier Quality Engineering Team Lead Job
Location: Raritan New Jersey
Description: Johnson & Johnson is looking of External Manufacturing & Supplier Quality Engineering Team Lead Job right now, this vacancy will be placed in New Jersey. More complete informations about this vacancy opportunity please read the description below. Johnson & Johnson companies are equal opportunity employers.
External Manufacturing & Supplier Q! uality Engineering Team Lead-4607130730
Description
Medical Devices & Diagnostics Global Services, LLC. a member of the Johnson & Johnson Family of Companies, is recruiting for an External Manufacturing and Supplier Quality Engineering Team Lead located in Raritan, NJ. The External Manufacturing and Supplier Quality Engineering Team Lead will support the Ortho Clinical Diagnostics (OCD) franchise within the Global Medical Solutions Group.
Medical Devices & Diagnostics Global Services, LLC., represents more than 60 manufacturing sites and 26,000 employees who plan, source, manufacture and deliver high-quality and cost-effective medical products to our customers around the globe each day. Work of the Medical Devices & Diagnostics Supply Chain (MD&D SC) supports a multitude of product platforms, new products and delivery systems that are used in a wide range of procedures throughout the healthcare industry, including interventional cardiology, electr! ophysiology, minimally invasive surgery, hospital sterilizatio! n, clinical laboratory testing, diabetes management, joint replacement surgery and vision care.
Ortho Clinical Diagnostics (OCD) serves the transfusion medicine community and clinical laboratories around the world. We're a leading provider of total solutions for screening, diagnosing, monitoring and confirming diseases early, before they put lives at risk. Our single focus is to help hospitals, laboratories and blood centers worldwide deliver results that help patients experience a better quality of life. For more information please visit www.orthoclinical.com
The External Manufacturing & Supplier Quality Engineering Team Lead will be accountable for the oversight of the Transfusion Medicine and Cellular Technologies (inclusive of Raritan, Veridex, and MTS) lines of business supply base. Serves as the lead Supplier Quality Engineer and has accountability for the leadership and direction of EM&SQ Quality Engineers in the execution of the supplier quality pr! ogram and in day to day activities that support manufacturing and external manufacturing operations.
Implement supplier quality oversight via active review and management of non-conformances, creation and review of quality metrics, and developing and maintaining effective working relationships with critical suppliers consistent with a quality oversight model. Lead supplier evaluation and risk assignment segmentation, manage Supplier Performance Scorecard process, and analyze and identify emerging supplier non-conformance trends using appropriate statistical tools and presentation of data for Supplier Management Reviews.
The External Manufacturing & Supplier Quality Engineering Team Lead will monitor quality performance of suppliers and external manufacturers participate in technical assessments & quality system audits of suppliers to identify potential areas of risks, process variability and address root causes. Using Six Sigma methodology, perform process! variability studies, risk analysis, test method variability. Lead or s! upport teams to investigate quality issues (Failure investigations) to resolve complaints, non-conforming products and CAPA. Provides and drives strategic direction for the investigation as they relate to quality elements. Works independently to issue and investigate supplier delivery, quality, and compliance related non-conformances using a systematic approach to problem solving, conducting risk analyses and drive of corrective and preventative actions. Participate and collaborate with Supply Chain, R&D Engineering, Operations Engineering and Manufacturing to identify potential areas of process variability, address root causes and implement improvements. Leads/participates preparation of Process/Design Failure Mode and Effects Analysis (PFMEA /DFMEA). Participates in new product development team activities in the development and qualification of suppliers.
Serves as key contributor to the purchasing controls area of the quality system, ensuring alignment to the di! rection of MD&D and J&J enterprise standards. Maintain working level knowledge of current industry and international regulations and standards appropriate to medical devices, IVDs, pharmaceuticals, and biologics. Periodically will lead or provide technical support to a variety of audit needs (e.g., compliance, supplier, OEM due diligence, audit readiness).
Qualifications
A Bachelor’s degree and a minimum of 9 years of experience within the Pharmaceutical, Medical Device, or other highly regulated industry is required. A degree in a technical field, preferable Science or Engineering, and an MS/MBA is preferred. Process Excellence Certification (e.g. Black Belt/Green Belt), ASQ: CQA, and/or CQE certification is highly preferred. Working knowledge of regulatory and compliance environment (e.g. 21 CFR Parts 820) is highly preferred. Supplier Quality experience is preferred. Experience working on or leading a Quality Systems improvement project is preferred. ! Previous supervisory experience is preferred. Writing and communication! proficiency, the ability to prioritize tasks to meet deadlines along with the ability to develop a wide range of solutions for manufacturing and supplier problems, and the ability to understand business implications related to projects and opportunities is required. This position may require up to approximately 30% domestic and international travel. This position will be based in Raritan, NJ.
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
Primary Location: North America-United States-New Jersey-Raritan
Organization: OCD Inc. (6118)
Job : Quality (Eng)
Relocation: Eligible
No
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 sponsor! ed program and to see a list of the sites that are currently enrolled, please click here.
- .
If you were eligible to this vacancy, please email us your resume, with salary requirements and a resume to Johnson & Johnson.
If you interested on this vacancy just click on the Apply button, you will be redirected to the official website
This vacancy starts available on: Sun, 01 Sep 2013 22:29:29 GMT
Apply External Manufacturing & Supplier Quality Engineering Team Lead Job Here