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Quality Engineer II

Job Summary

The Quality Engineer II will provide hands on QE support for Engineering and Production.  He/she will provide audit support for third party audits and customer audits as well as perform internal audits and supplier audits.  He/she will also interact with customers and suppliers in support of engineering projects.

Duties and Responsibilities

  • Develop quality systems and procedures as required to meet statutory or regulatory requirements
  • Review document and procedure changes for quality requirements and compliance with the quality system  Provide quality support for the disposition of material
  • Support the implementation of continuous improvement initiatives for operations
  • Ability to comply with company policies/procedures pertaining to safety, health, quality, QSR’s, and the Quality Management System
  • Knowledge of Lean Six Sigma manufacturing practices
  • Knowledge of MS Word and Excel
  • Provide resource allocation of quality support
  • Provide first Quality contact for customer complaint handling
  • Provide sponsorship and act as facilitator for SPC, FMEA, DOE and process validation systems
  • Facilitate development and implementation of IQ, OQ and PQ to ensure compliance with the Quality System
  • Provide QE support, analysis, and recommendations for Product Development to successfully launch new products into active production in a timely and cost‐effective manner
  • Ability to follow established guidelines to daily maintain a safe, clean, and organized work area
  • Willingness to work as a team member
  • Other duties as assigned

Required Skills/Abilities

  • Must be familiar with and understand recognized regulations and standards such as (where applicable) o 21 CFR Part 820 (FDA QSR, cGMP) o ISO 13485 Medical Devices – Quality Management Systems o ISO 14971 Risk Management o ISO 9001 Quality Management Systems
  • Demonstrated leadership skills
  • Able to be technically comprehensive and knowledgeable including standard business ERP system principles, as well as technical aspects such as statistics, documentation, SPC, Geometric Tolerancing, and mechanical drawings and associated software packages
  • Familiar with Six Sigma and/or a history of lean manufacturing, Kaizen and 5S, etc.
  • Six‐Sigma certified or willing to obtain certification preferred
  • Must possess excellent verbal & written communication skills, as well as presentation, organizational and management skills
  • Prior experience with environmental controls, biocompatibility and associated control systems preferred
  • Knowledge of machining, metals and plastics processing and fabrication, and product assembly in the medical device industry
  • Ability to adapt to frequent changes, delays, or unexpected events in the work environment
  • Strong time management skills to meet assigned deadlines
  • Excellent organizational and attention to detail skills
  • Ability to interface with customers, problem solve and drive solutions to meet customer requirements
  • Strategic thinker – responsible for contributing to the development of the plan; ability to conceptualize coherent view of facility in the future (six months, one year, two years, five years)
  • Must possess excellent verbal, written, and presentation communication skills
  • Rational thinker – good business judgment and ethics
  • Strong communicator with internal and external customers (written and verbal) (one‐on‐one and group)
  • Entrepreneurial attitude and mindset combined with the appropriate process orientation, focus and willing to embrace change
  • Self‐motivated with a sense of urgency and accountability
  • Energetic and hardworking
  • High level of intellectual curiosity combined with strong problem solving and analytical skills
  • Innovative, practical, technically astute, and capable of healthy dialogue in the exchange of ideas in reaching conclusions
  • Ability to act with professionalism, integrity, and superior confidentiality
  • Ability to assess own strengths/opportunities; pursues training and development opportunities, striving to continuously build knowledge and skills

Education and Experience

  • Typically, Bachelor’s degree in engineering, equivalent degree, or extensive work experience
  • Minimum eight (8) years’ equivalent work experience in lieu of education.
  • Minimum four (4) to twelve (12) years’ experience in manufacturing, preferably medical devices, pharmaceuticals, aerospace, food, automotive or other regulated industries, including at least three years leadership responsibilities with increasing responsibility in quality assurance or associated fields

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