Quality Manager

POSITION SCOPE/SUMMARY

Provides quality system leadership for the entire facility

POSITION REQUIREMENTS

  • Responsible for compliance to 21 CFR 820, ISO 13485, Quality Manual and companywide policies
  • Acts as Facility liaison to division and is responsible for managing the Quality System
  • Final authority to reject or accept product
  • Responsible for creating and delegating new employee training into the quality system as well as annual training for all existing employees
  • Review operation processes and verify that proper gaging methods and proper frequencies are on inspection sheets
  • Management of Document Control to maintain Quality System Documentation, Device Master Record, Document Control, Request for Change, and External Standards
  • Management of Gage Calibration system
  • Support implementation and continuous improvement of processes through SOP’s, CAPA, supplier auditing and Management Reviews
  • Administer effective internal audits of the Quality System
  • Maintain customer complaint log, documenting returns and corrective actions to returns
  • Run Quality Dept. with employees who are trained to perform their assignments in a professional and timely manner.  Ensure properly staffed department
  • Reduce variation in gaging processes by implementing and monitoring most recent technologies in gaging
  • Automate inspection methods where possible to reduce manual inspections
  • Maintain corrective action system and review effectiveness and implementation of corrective actions
  • Performs other duties as necessary

ENVIRONMENTAL WORKING CONDITIONS

The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions

  • Ability to spend time using your hands to handle, control, or feel objects, tools or controls
  • Occasionally required to stoop, kneel, bend, crouch, bend and twist
  • Ability to work in a demanding user environment
  • Ability to analyze, understand and effectively communicate technical material
  • Job requires sitting, standing, bending and reaching

QUALIFICATIONS

  • Familiarity with ISO and FDA Regulations
  • Minimum of 5 years’ experience in a manufacturing environment, preferably related to the medical field
  • Skilled in the use of statistics and root cause analysis as they relate to production
  • Excellent communications and organizational skills
  • Able to manage multiple priorities with many time constraints
  • Excellent computer skills, utilizing word processing, spreadsheets, project software and statistical software as well as job control software

EDUCATION

  • Minimum of a Bachelor’s Degree in field relating to engineering, manufacturing, or quality

It is impossible to list every requirement for, or responsibility of, any position.  Similarly we cannot identify all the skills a position may require since job responsibilities and the Company’s needs may change over time.  Therefore, the above job description is not comprehensive or exhaustive.   The Company reserves the right to adjust, add to or eliminate any aspect of the above description.  The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.

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.