Quality Manager

DESCRIPTION

This is a highly responsible, independent, supervisory position responsible for all aspects of the quality improvement process. This position requires strong medical manufacturing, customer relations, organizational, and leadership skills, as well as a working knowledge of quality control measures and quality control programs in an ISO 13485 environment.

RESPONSIBILITIES

  • Coach, mentor, develop, direct, train, and evaluate the work of quality improvement personnel
  • Maintain a robust Quality Management System that meets all FDA and ISO 13485 requirements
  • Ensure customer satisfaction with product quality
  • Receive and provide communications and related materials and reports regarding parts revisions, parts on hold, questions on dimensions, parts rejections, parts changes, qualifications, validations, internal audit data, and other quality-related information the customer requires
  • Receive, interpret, and implement corrective action procedures for product quality that the customer requires
  • Implement changes in the process/procedures requirements to improve product quality
  • Oversee the internal audit and CAPA programs
  • Supervise responsibilities outlined in the Quality Floor Inspector, Quality Inspector, and Quality Engineer job descriptions
  • Perform other tasks as assigned

REQUIREMENTS

  • Knowledge and familiarity with optical gauging products (OGP), coordinate measuring machines (CMM), and other measuring devices used to ensure product quality and acceptability
  • Ability to read and interpret blueprints
  • Familiarity with geometric dimension & tolerance (GDT) procedures and requirements
  • Ability to use nonconformance data to determine trends and any changes necessary to eliminate rejections and/or procedural problems
  • Ability to perform computer-related tasks using software including: Microsoft Office, Access, Minitab, and/or others related to the Quality Improvement Department

EDUCATION

  • Bachelor’s degree in an applicable technical field with 8+ years of experience
  • Master’s degree is a plus

PHYSICAL REQUIREMENTS

  • Light work: Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or lifting, carrying, pushing, pulling or otherwise moving objects

VISUAL ACUITY

  • Worker is required to have close visual acuity to perform activities such as:
    • Preparing and analyzing data and figures
    • Transcribing
    • Viewing a computer screen
    • Extensive reading
    • Visual inspection involving small defects, small parts, and/or operating machines
    • Using measurement devices
    • Assembly or fabrication of parts at distance close to the eyes

CONDITIONS

  • Worker is not exposed to adverse environmental conditions (as in typical office or administrative work)

Position locations: Chicopee, MA, Fremont, CA, South Plainfield, NJ

Apply Now

ABOUT VIANT

At Viant, we focus on providing end-to-end solutions for medical device OEMs. Our deep materials expertise—combined with our experience in engineering, manufacturing, assembly, packaging, and sterilization—allows us to bring our customers’ healthcare solutions to market. We have facilities across the U.S. and around the world, including low-cost facilities in Costa Rica, China, Mexico, and Puerto Rico.

Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.