Quality Engineer in Manchester, NH at Tecomet

Date Posted: 10/2/2019

Job Snapshot

Job Description

JOB SUMMARY: 

The position provides overall quality leadership and direction to meet customer quality requirements, create, monitor and improve quality programs, reduce quality costs and maintain compliance within FDA and ISO regulations for the Manchester, NH facility.  This is accomplished by maintaining Tecomet’ principles of Safety, Quality, Customer Satisfaction and Innovation.

ESSENTIAL FUNCTIONS:

  • Maintaining applicable quality system, environmental, and FDA requirements/certifications.

  • Facilitate operator owned quality program

  • Work with team members and support manufacturing/operations to solve quality, cost and schedule issues.

  • Prepare FMEA’s, controls plans, quality plans, PPAP

  • Coordinate process validations and reduce dependence on inspection.

  • Generating applicable quality metric reports; cost of quality, management by facts.

  • Supporting the MRB and RMA processes.

  • Investigate customer complaints including associated actions including CAPA, deviations, and complaint responses.

  • Special projects as assigned by the Director of Quality.

CORE TECHNICAL SKILLS:

  • Knowledge of medical device, FDA & ISO 13485.

  • Strong knowledge in manufacturing operations.

  • Lean manufacturing experience.

  • Highly organized and self-motivated to complete projects on time; leader to execute quality improvement initiatives.  

  • Ability to communicate professionally to common inquiries or complaints from customers, or regulatory agencies.

  • Ability to define problems, collect data, establish facts, and interpret technical instructions.

  • Ability to apply advanced mathematical concepts and apply mathematical operations to determine such tasks as test reliability and validity, correlation techniques and factor analysis.

  • Ability to effectively present information and respond to questions from teammates, direct reports, management, and internal and external customers.

  • Proficient in Microsoft Office Suite.

  • Meet goals and objectives set for department and company.

 CORE EXPERIENCE & EDUCATION:

  • Minimum Associates Degree and 3 plus years of experience in a quality related field or equivalent combination of education and experience.

  • Medical Device Manufacturing, CAPA, Validations and customer interaction experience required

  • ASQ Certification Preferred

WORKING CONDITIONS/PHYSICAL ABILITIES:

  • Well lighted, heated/or air-conditioned indoor office/production setting with adequate ventilation.

  • Light physical activity performing non-strenuous daily activities of a primarily administrative nature.

  • Ability to occasionally lift and/or move up to 10 pounds.

  • Ability to maneuver throughout the facility/facilities as needed.

  • Manual dexterity sufficient to reach/handle items and work with fingers.

  • Ability to wear proper PPE

TRAVEL REQUIREMENTS:    

Can be expected to travel to customers, suppliers etc. as needed

Tecomet is an Equal Opportunity Employer M/W/VET/DISABLED