Discovery Personnel Jobs » Quality http://www.discoverypersonnel.com/jobs Jobs in the Plastics Industry Sun, 05 Sep 2010 21:04:04 +0000 en hourly 1 http://wordpress.org/?v=3.0.1 Vice President of Quality and Requlatory Affairs – Montpelier, VT http://www.discoverypersonnel.com/jobs/?p=447 http://www.discoverypersonnel.com/jobs/?p=447#comments Sat, 03 Jul 2010 15:47:27 +0000 Administrator http://www.discoverypersonnel.com/jobs/?p=447 Description
A growing and highly regarded custom medical and automotive injection molding company is searching for a Vice President of Quality and Regulatory Affairs. The Vice President of Quality and Regulatory Affairs (VPQRA) is responsible for establishing the strategic direction for continuous quality improvement and the implementation of corporate quality policies globally across all facilities. The VPQRA will benchmark best practices for the sustained improvement of critical quality and business processes throughout the corporation. The VPQRA works with senior management to identify areas of improvement, creates projects, gathers resources to work on projects, and manages the progress of projects to support the company’s short and long-range business objectives. This individual will oversee the deployment of quality analysis tools and will act as a resource for front line Quality Managers, Executive Management and other members of the Management Team.

SPECIFIC RESPONSIBILITIES:

  • Lead company-wide initiatives related to developing, implementing, streamlining, and strengthening quality and environmental systems, which comply with ISO 9001, ISO/TS 16949, ISO 13485, ISO 14001, GHTF Guidelines, FDA QSR and ISO 28000.
  • Lead company SPC efforts while promoting standardization among plant practices, documentation, and systems related to Quality, Manufacturing and Engineering.
  • Support New Program Launch Design Review Meetings and engage with project teams on IQ/OQ/PQ activities including FMEA and Control Plan review to ensure consistency.
  • Review and/or negotiate customer-specific requirements and manuals to ensure that corporate quality systems comply with such customer expectations.
  • Manage the company’s corporate internal audit function and actively support layered audit programs by personally conducting quality system and process-level audits at various company locations.
  • Function as the main interface with regulatory and registration bodies; negotiate contracts and ensure internal compliance.
  • Provide regulatory, GMP and medical device/pharmaceutical expertise to advance the corporation’s medical device assembly and contract manufacturing business.
  • Manage/Delegate supplier quality activities including supplier selection, supplier corrective actions, supplier audits, and administration of the Supplier Excellence Manual.

    • In addition to an annual salary in the $100,000 to $125,000 range, the company offers very competitive medical benefits, a 401k with matching, a very good relocation package, etc.

    Requirements

  • Four year Engineering, Science or Math degree is required and an MBA/MA is preferred.
  • Minimum of 12 years of quality management experience (at the director level or above) with specific experience in the custom injection molding of medical devices/components and automotive parts (PPAP and related automotive industry practices).
  • ASQ Certified Quality Engineer, Quality Auditor, Quality Manager, Six Sigma Black Belt or similar achievements preferred.
  • Computer literate in programs such as Word, Excel, PowerPoint, etc.
  • Strong SPC knowledge and application experience.
  • Well versed in TS 16949, ISO 9001, 13485, and FDA’s Title 21 CFR’s.
  • Familiarity with medical/FDA guidelines as applies to manufacturing processes and related documentation, and/or direct experience with medical device manufacturing. FDA Regulatory exposure and/or RAC certification a plus.
  • Practitioner level – Lean Manufacturing experience with a record of accomplishment in leading Kaizen events, VSM and overall process improvement activities.
  • Knowledge and experience in control plan development, product print and specification understanding, customer interface experience.
  • Knowledge of molding process and procedures.
  • Excellent written and verbal communications skills.
  • Ability to travel as needed
    • ]]>     http://www.discoverypersonnel.com/jobs/?feed=rss2&p=447 0     Injection Molding Manufacturing Quality Engineer – Randolph, VT http://www.discoverypersonnel.com/jobs/?p=395 http://www.discoverypersonnel.com/jobs/?p=395#comments Sat, 01 May 2010 16:13:15 +0000 Administrator http://www.discoverypersonnel.com/jobs/?p=395 Description
    A growing and well regarded custom injection molding company is searching for a Manufacturing Quality Engineer. The Manufacturing Quality Engineer is responsible for the quality assurance of all products, quality system management, manufacturing process quality and customer problem resolution.

      SPECIFIC RESPONSIBILITIES:
  • Participates in product design reviews and Tech Center hand-off approval.
  • Resolution of internal product quality problems.
  • Resolves product customer complaint cause and corrective action analysis.
  • Customer on-site quality resolution and/or quality reviews.
  • Supervision of QA Auditors.
  • Specific production quality training for QA Auditors, IPI’s, and MQT’s.
  • Manufacturing process quality management (including insert molding process).
  • Development and maintenance of QAR (Quality Assurance Report) books.
  • Audits injection molding processes against the Master Process & Control Plans
  • Development and maintenance of QAR (quality Assurance Report) books
  • Medical product quality validation after mold repair, including capability studies, gauge R & R’s, first article reports, etc.
  • Development and maintenance of SPC database for medical components
  • Manage quality assurance operations during QA Manager absence
  • Daily inspection of product/processes
  • Internal Audits, Customer Audits, and ISO/QS Audits
  • Assist in procedure development and/or maintenance
  • ECN Approval for Automotive/CI products
  • Automotive/CI product quality validation after mold repair
  • MRB disposition of Automotive/CI products
  • Development and maintenance of the Applied Statistics database
  • Member of Internal Auditing Team

    • The company injection molds plastic parts for the medical, consumer and automotive industries in a modern molding facility with clean rooms for the medical molding operations.

    In addition to an annual salary in the $60,000 to $75,000 range, the company offers very competitive medical benefits, a 401k with matching, relocation, etc.

      REQUIREMENTS:
  • Four year Engineering or Science degree
  • Minimum of 5 years quality engineering experience, with specific experience in medical devices/components desired
  • Knowledge of measurement equipment and experience in measurement equipment, including calipers, micrometers, tool scopes, optical comparators, and vision systems
  • Computer literate in programs such as Word, Excel, PowerPoint
  • Strong SPC knowledge and experience
  • Knowledge and experience in control plan development, product print and specification understanding, customer interface experience
  • Knowledge of molding process and procedures
  • Experience in molded product quality control desired FDA/ISO/QS system knowledge and experience (any or all)
  • Good communication skills
  • Certified Quality Auditor and/or Quality Engineer highly desirable
  • Ability to travel when needed
    • ]]>     http://www.discoverypersonnel.com/jobs/?feed=rss2&p=395 0