Bachelor's degree in Engineering, Science, or Math (Statistics)
1-3 years of Quality Engineering experience in a manufacturing or FDA regulated environment
Knowledge of ISO, FDA, and QSR regulations
Ability to read blueprints and interpret GD&T
Experience with quality audits and continuous improvement methodologies
Excellent communication and problem-solving skills
Proficient in MS Office Suite, Visio, and Project
Responsibilities
Provide technical support for customer complaint investigations
Facilitate Non-conformance and MRB activities
Execute Risk Management activities
Identify statistically based sampling plans for inspections
Support validations for products, processes, and equipment
Ensure compliance with cGMP, QSR, ISO13485, and other regulations
Participate in FDA inspections and customer audits
Implement opportunities for continuous improvement
Benefits
Support for professional development and certifications
Collaborative work environment
Opportunities for continuous improvement initiatives
Engagement in diverse quality system activities
Exposure to FDA and ISO regulatory processes
Full Job Description
POSITION SUMMARY
The desired candidate will have prior experience working as a Quality Engineer, preferably working in a medical device company. Specific experience and responsibilities will include, but not limited to, providing Quality and Compliance related support to the manufacture and distribution of medical devices in accordance with applicable medical standards and regulations (ISO 13485, 21 CFR 820, etc.).
ESSENTIAL FUNCTIONS/MAJOR RESPONSIBILITIES:
Provide technical support for review and approval of customer complaint investigations
Facilitate Non conformances and MRB activities
Facilitate the execution of Risk Management activities
Identify statistically based sampling plans for inspections and validations
Support validations for new and existing products, processes and equipment
Ensure compliance with cGMP, QSR, ISO13485, MDD, and other applicable regulations/standards
Participate in FDA inspections, ISO Registration and surveillance audits and customer audits
Identify and implement opportunities for continuous improvement
Interact and coordinate activities with other departments, external vendors and customers
Assist or lead in the identification and implementation of CAPA
Aid in the implementation of the SPC control system with Manufacturing and Quality Control
Support internal quality system audits
Provide support necessary for supplier controls, including but not limited to: supplier audits
Participate in Post-Market Surveillance (PMS) activities as required
Collect and report metrics and data as required
Perform other Quality System related duties as required
MINIMUM REQUIREMENTS:
Minimum of bachelor's degree, preferably in Engineering, Science (Biology, Chemistry, Physics, etc.) or Math (Statistics)
1-3 yrs Quality Engineering experience in a manufacturing or industrial environment, preferably in an FDA regulated environment
PREFERRED SKILLSET:
Knowledge of statistical sampling and analysis
Knowledge of ISO, FDA, and QSR concepts and guidelines as well as other national and international regulations and standards
Ability to read blueprints and interpret Geometric Dimensioning and Tolerances (GD&T)
Experience performing quality audits and utilizing manufacturing processes, techniques, and continuous improvement methodologies (i.e, Six Sigma, Lean manufacturing, etc.).
Certified Quality Auditor (ASQ CQA) or Certified Quality Engineer (ASQ CQE) would be a plus
Excellent organizational, verbal, written communication and problem-solving skills
Possess above-average interpersonal skills demonstrating the ability to work with others in a professional, positive and collaborative manner
Ability to work in a fast-paced environment and to meet tight deadlines
Willingness to learn, possess a can-do attitude, and motivated to succeed and grow
Ability to problem solve, and multi-task with strong attention to detail
Proficient in MS Office Suite, Visio and Project
Experience working in a start-up environment, helpful
